Trial Outcomes & Findings for Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma (NCT NCT01729338)
NCT ID: NCT01729338
Last Updated: 2017-05-31
Results Overview
Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria: IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 8 months
Results posted on
2017-05-31
Participant Flow
17 subjects consented to the study. 1 subject was a screen failure.
Participant milestones
| Measure |
Velcade, Cyclophosphamide, Revlimid
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Age, Continuous
|
76.5 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 8 monthsDefined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria: IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Overall Response Rate (ORR) During Induction Therapy
|
64 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Severe Adverse Event Rate
|
64 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 monthsMaximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Maximum Depth of Response During Induction Therapy
Complete Response/Stringent complete response
|
29 percentage of participants
|
|
Maximum Depth of Response During Induction Therapy
Progressive Disease/no response
|
14 percentage of participants
|
|
Maximum Depth of Response During Induction Therapy
Stable Disease
|
21 percentage of participants
|
|
Maximum Depth of Response During Induction Therapy
Partial Response
|
7 percentage of participants
|
|
Maximum Depth of Response During Induction Therapy
Very good partial response (VGPR)
|
29 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: 8 of all subjects reached maintenance and could be analyzed
Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy. IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=8 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Maximum Depth of Response During Maintenance Therapy
Stable Disease
|
13 percentage of participants
|
|
Maximum Depth of Response During Maintenance Therapy
Partial Response
|
0 percentage of participants
|
|
Maximum Depth of Response During Maintenance Therapy
Very good partial response
|
50 percentage of participants
|
|
Maximum Depth of Response During Maintenance Therapy
Complete Response/Stringent complete response
|
38 percentage of participants
|
|
Maximum Depth of Response During Maintenance Therapy
Progressive Disease/no response
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 monthsDefined as median time to achievement of response (partial remission or better by International Myeloma Working Group standard criteria), in study subjects during 8 months of induction chemotherapy.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Median Time to Response
|
2 months
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: From date of first confirmed response until date of disease progression or up to 3 yearsPopulation: 9 out of all patients achieved response and hence could be analyzed for duration of response
Defined as median time elapsed in study subjects between achievement of response and disease progression.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=9 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Median Duration of Response
|
26.2 months
Standard Deviation 0.207
|
SECONDARY outcome
Timeframe: 4 yearsDefined as median time elapsed in study subjects between initiation of study therapy and either disease progression or death, regardless of cause of death.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Median Progression-free Survival
|
24.2 months
Standard Deviation 0.157
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as median time elapsed in study subjects between initiation of study therapy and death, regardless of cause.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Median Overall Survival
|
29.7 months
Standard Deviation 0.189
|
SECONDARY outcome
Timeframe: baseline, 3 months, 5 monthsPopulation: Participants who completed questionnaire.
Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=10 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
QLQ-C30 Question 29
Baseline
|
58.3 units on a scale
Standard Deviation 22.6
|
|
QLQ-C30 Question 29
3 months
|
65 units on a scale
Standard Deviation 18.9
|
|
QLQ-C30 Question 29
5 months
|
68.3 units on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: baseline, 3 months, 5 monthsPopulation: Participants who completed questionnaire.
Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=10 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
QLQ-C30 Question 30
Baseline
|
51.7 units on a scale
Standard Deviation 24.1
|
|
QLQ-C30 Question 30
3 months
|
66.7 units on a scale
Standard Deviation 19.7
|
|
QLQ-C30 Question 30
5 months
|
66.7 units on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants who completed functionality assessment at baseline. Data were incompletely and irregularly collected after baseline so unable to analyze additional time points.
Mean functionality in study subjects, quantitatively scored using the standardized and validated Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool, which comprehensively assesses aspects of a patient's functionality such as symptoms (e.g., pain, anxiety), social support (e.g., someone to turn to for help), and ability to carry out routine activities (e.g., grocery shopping) or physical exertion (e.g., climbing stairs) was assessed at baseline. The score is obtained by inserting patient-specific data into the online calculator found at http://www.mycarg.org/Chemo\_Toxicity\_Calculator, which is based on the risk score described in Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011;29(25):3457-3465. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk for severe (grade \>2) toxicity.
Outcome measures
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=13 Participants
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool
|
10 Scores on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Day 1Population: Data for the risk score wasn't recorded correctly, and therefore we were unable to analyze the data.
Calculation of the risk score requires that the patient be assessed with the CALGB Assessment Tool, which has both a patient self-reporting questionnaire and a clinician assessment. Both will be used in this trial, and thus patients will have risk scores based on their own self-assessments and risk scores based on the clinicians' assessment. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk. The distribution of the risk score in this trial will be described by plotting the median of the risk score against time, with patient and clinician assessments overlaid on the same plot.
Outcome measures
Outcome data not reported
Adverse Events
Velcade, Cyclophosphamide, Revlimid
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 participants at risk
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Injury, poisoning and procedural complications
Fracture
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Paresthesia
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Delirium
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
|
Vascular disorders
Hematoma
|
7.1%
1/14 • 1st day of drug till 30 days after last dose
|
Other adverse events
| Measure |
Velcade, Cyclophosphamide, Revlimid
n=14 participants at risk
INDUCTION (28-day cycles for 8 cycles):
* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15
* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15
* Dexamethasone 40 mg PO days 1,8 and 15
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21
* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
7/14 • Number of events 19 • 1st day of drug till 30 days after last dose
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Cardiac disorders
Chest pain - cardiac
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
2/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Eye disorders
Blurred vision
|
14.3%
2/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Eye disorders
Conjunctivitis
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Eye disorders
Eye disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Eye disorders
Eye pain
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 5 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Number of events 12 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
8/14 • Number of events 20 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
2/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14 • Number of events 11 • 1st day of drug till 30 days after last dose
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
5/14 • Number of events 11 • 1st day of drug till 30 days after last dose
|
|
General disorders
Chills
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
General disorders
Edema limbs
|
57.1%
8/14 • Number of events 10 • 1st day of drug till 30 days after last dose
|
|
General disorders
Fatigue
|
57.1%
8/14 • Number of events 15 • 1st day of drug till 30 days after last dose
|
|
General disorders
Fever
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
General disorders
Gait disturbance
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
General disorders
Injection site reaction
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
General disorders
Malaise
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Immune system disorders
Immune system disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Bronchial infection
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Eye infection
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Skin infection
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Upper respiratory infection
|
21.4%
3/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
21.4%
3/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Investigations
Creatinine increased
|
35.7%
5/14 • Number of events 8 • 1st day of drug till 30 days after last dose
|
|
Investigations
Neutrophil count decreased
|
35.7%
5/14 • Number of events 8 • 1st day of drug till 30 days after last dose
|
|
Investigations
Platelet count decreased
|
21.4%
3/14 • Number of events 9 • 1st day of drug till 30 days after last dose
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
2/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.1%
1/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14 • Number of events 6 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
3/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
3/14 • Number of events 7 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.6%
4/14 • Number of events 7 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
21.4%
3/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
21.4%
3/14 • Number of events 6 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Dizziness
|
35.7%
5/14 • Number of events 7 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Memory impairment
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Paresthesia
|
7.1%
1/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.7%
5/14 • Number of events 9 • 1st day of drug till 30 days after last dose
|
|
Nervous system disorders
Presyncope
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Anxiety
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Depression
|
21.4%
3/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Insomnia
|
28.6%
4/14 • Number of events 8 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Libido decreased
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Renal and urinary disorders
Urinary frequency
|
28.6%
4/14 • Number of events 6 • 1st day of drug till 30 days after last dose
|
|
Renal and urinary disorders
Urinary incontinence
|
21.4%
3/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Renal and urinary disorders
Urinary tract pain
|
14.3%
2/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Renal and urinary disorders
Urinary urgency
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.7%
5/14 • Number of events 14 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
4/14 • Number of events 6 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
21.4%
3/14 • Number of events 5 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
28.6%
4/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
57.1%
8/14 • Number of events 16 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
7.1%
1/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.4%
3/14 • Number of events 4 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Purpura
|
7.1%
1/14 • Number of events 1 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
2/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
28.6%
4/14 • Number of events 7 • 1st day of drug till 30 days after last dose
|
|
Vascular disorders
Hot flashes
|
21.4%
3/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Vascular disorders
Hypertension
|
14.3%
2/14 • Number of events 3 • 1st day of drug till 30 days after last dose
|
|
Vascular disorders
Vascular disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • 1st day of drug till 30 days after last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place