Trial Outcomes & Findings for Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma (NCT NCT00433537)
NCT ID: NCT00433537
Last Updated: 2014-10-30
Results Overview
Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Assessed after VcR-CVAD cycles 2, 4, and 6.
Results posted on
2014-10-30
Participant Flow
Participant milestones
| Measure |
VcR-CVAD Induction Followed by Maintenance Rituximab
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
VcR-CVAD Induction Followed by ASCT
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.
|
VcR-CVAD Induction Then Off Study
Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
|
|---|---|---|---|
|
Step 1 - VcR-CVAD Induction
STARTED
|
45
|
22
|
10
|
|
Step 1 - VcR-CVAD Induction
Eligible and Treated
|
44
|
22
|
9
|
|
Step 1 - VcR-CVAD Induction
COMPLETED
|
44
|
22
|
1
|
|
Step 1 - VcR-CVAD Induction
NOT COMPLETED
|
1
|
0
|
9
|
|
Step 2 - Maintenance Rituximab or ASCT
STARTED
|
45
|
22
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
Eligible and Treated
|
44
|
22
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
COMPLETED
|
29
|
22
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
NOT COMPLETED
|
16
|
0
|
0
|
Reasons for withdrawal
| Measure |
VcR-CVAD Induction Followed by Maintenance Rituximab
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
VcR-CVAD Induction Followed by ASCT
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.
|
VcR-CVAD Induction Then Off Study
Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
|
|---|---|---|---|
|
Step 1 - VcR-CVAD Induction
Path ineligible (not having MCL)
|
1
|
0
|
1
|
|
Step 1 - VcR-CVAD Induction
Lack of Efficacy
|
0
|
0
|
2
|
|
Step 1 - VcR-CVAD Induction
Adverse Event
|
0
|
0
|
4
|
|
Step 1 - VcR-CVAD Induction
Withdrawal by Subject
|
0
|
0
|
2
|
|
Step 2 - Maintenance Rituximab or ASCT
Path ineligible (not having MCL)
|
1
|
0
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
Lack of Efficacy
|
8
|
0
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
Adverse Event
|
2
|
0
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
Alternative therapy
|
4
|
0
|
0
|
|
Step 2 - Maintenance Rituximab or ASCT
Other
|
1
|
0
|
0
|
Baseline Characteristics
Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Step 1 - VcR-CVAD Induction
n=75 Participants
All eligible patients who received VcR-CVAD induction.
|
|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Assessed after VcR-CVAD cycles 2, 4, and 6.Population: Eligible and treated patients
Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.
Outcome measures
| Measure |
VcR-CVAD Induction
n=75 Participants
All eligible patients who received VcR-CVAD induction.
|
VcR-CVAD Induction Followed by ASCT
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.
|
|---|---|---|
|
Complete Response (CR) Rate
|
0.68 proportion
Interval 0.57 to 0.79
|
—
|
SECONDARY outcome
Timeframe: Assessed every 6 months for 5 years, and then yearly thereafter.Population: Eligible and treated patients who received maintenance rituximab or ASCT
PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
Outcome measures
| Measure |
VcR-CVAD Induction
n=44 Participants
All eligible patients who received VcR-CVAD induction.
|
VcR-CVAD Induction Followed by ASCT
n=22 Participants
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.
|
|---|---|---|
|
2-year Progression-free Survival (PFS)
|
0.79 probability
Interval 0.67 to 0.92
|
0.76 probability
Interval 0.58 to 1.0
|
SECONDARY outcome
Timeframe: Assessed every 6 months for 5 years, and then yearly thereafter.Population: Eligible and treated patients who received maintenance rituximab or ASCT
OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored.
Outcome measures
| Measure |
VcR-CVAD Induction
n=44 Participants
All eligible patients who received VcR-CVAD induction.
|
VcR-CVAD Induction Followed by ASCT
n=22 Participants
VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy.
|
|---|---|---|
|
3-year Overall Survival (OS)
|
0.91 probability
Interval 0.83 to 1.0
|
0.96 probability
Interval 0.87 to 1.0
|
Adverse Events
Step 1 - VcR-CVAD Induction
Serious events: 72 serious events
Other events: 76 other events
Deaths: 0 deaths
Step 2 - Maintenance Rituximab
Serious events: 16 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1 - VcR-CVAD Induction
n=77 participants at risk
All patients who received VcR-CVAD induction.
|
Step 2 - Maintenance Rituximab
n=45 participants at risk
All patients who received maintenance rituximab.
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
22/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
2.2%
1/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Leukocytes decreased
|
67.5%
52/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
6.7%
3/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Lymphopenia
|
64.9%
50/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
26.7%
12/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Neutrophils decreased
|
80.5%
62/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
15.6%
7/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Platelets decreased
|
63.6%
49/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Vascular disorders
Hypotension
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
General disorders
Fatigue
|
10.4%
8/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
2.2%
1/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Psychiatric disorders
Insomnia
|
2.6%
2/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Weight gain
|
0.00%
0/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
2.2%
1/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.2%
4/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
2/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Typhlitis
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Upper GI, hemorrhage NOS
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.7%
9/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection w/ gr3-4 neut, catheter relate
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection Gr0-2 neut, catheter
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection Gr0-2 neut, heart
|
0.00%
0/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
2.6%
2/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
2.2%
1/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
2.6%
2/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.5%
5/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.6%
2/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.9%
3/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
2/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Nervous system disorders
Syncope
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Eye disorders
Keratitis
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Abdomen, pain
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Renal and urinary disorders
Cystitis
|
1.3%
1/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
Other adverse events
| Measure |
Step 1 - VcR-CVAD Induction
n=77 participants at risk
All patients who received VcR-CVAD induction.
|
Step 2 - Maintenance Rituximab
n=45 participants at risk
All patients who received maintenance rituximab.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
92.2%
71/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
57.8%
26/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Leukocytes decreased
|
50.6%
39/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
46.7%
21/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Lymphopenia
|
50.6%
39/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
60.0%
27/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Neutrophils decreased
|
44.2%
34/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
26.7%
12/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Platelets decreased
|
87.0%
67/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
42.2%
19/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
5.2%
4/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Vascular disorders
Hypotension
|
6.5%
5/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
General disorders
Fatigue
|
84.4%
65/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
28.9%
13/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
General disorders
Fever w/o neutropenia
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Psychiatric disorders
Insomnia
|
24.7%
19/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
General disorders
Rigors/chills
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Weight gain
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Weight loss
|
9.1%
7/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
6.7%
3/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.4%
28/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
13.3%
6/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.2%
4/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.5%
25/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Constipation
|
53.2%
41/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
6.7%
3/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
27.3%
21/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
10/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
6.5%
5/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
15.6%
12/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Nausea
|
68.8%
53/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Nervous system disorders
Taste disturbance
|
14.3%
11/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Vomiting
|
29.9%
23/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
General disorders
Edema limb
|
24.7%
19/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.4%
8/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Alkaline phosphatase increased
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Alanine aminotransferase increased
|
13.0%
10/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
10/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.0%
20/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Creatinine increased
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.8%
26/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
8.9%
4/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.5%
5/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
11/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
6.7%
3/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.9%
13/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Investigations
Metabolic/Laboratory-other
|
9.1%
7/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Nervous system disorders
Dizziness
|
11.7%
9/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Psychiatric disorders
Depression
|
5.2%
4/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Nervous system disorders
Neuropathy-sensory
|
36.4%
28/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
22.2%
10/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Eye disorders
Vision-blurred
|
6.5%
5/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Gastrointestinal disorders
Abdomen, pain
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
9.1%
7/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
13.0%
10/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Nervous system disorders
Head/headache
|
9.1%
7/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
5.2%
4/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
7.8%
6/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.6%
12/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.2%
4/77 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
0.00%
0/45 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Autologous stem cell transplantation (ASCT) was optional for this study, and submission of data with details on conditioning regimen or toxicity was not mandated. Therefore, the adverse event table for ASCT arm was not available.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60