Trial Outcomes & Findings for Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma (NCT NCT03477539)
NCT ID: NCT03477539
Last Updated: 2026-05-05
Results Overview
MRD negative response after ASCT is defined as achievement of MRD negative status in the bone marrow by flow cytometry (multiparameter flow cytometry \[MPF\]) at the day 100 post ASCT visit. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95 percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
100 days
Results posted on
2026-05-05
Participant Flow
Participant milestones
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Ineligible
|
3
|
Baseline Characteristics
Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.17 • n=54 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 100 daysMRD negative response after ASCT is defined as achievement of MRD negative status in the bone marrow by flow cytometry (multiparameter flow cytometry \[MPF\]) at the day 100 post ASCT visit. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95 percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT)
|
0.652 proportion of participants
Interval 0.505 to 0.779
|
SECONDARY outcome
Timeframe: 3 yearsThis will be estimated by the number of patients who achieve MRD negative status by flow cytometry (MPF) in the bone marrow after pre-SCT consolidation with daratumumab divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of MRD negative response after pre-SCT consolidation with daratumumab will be calculated.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
The Rate of MRD Negative Response After Pre-stem Cell Transplant (SCT) Consolidation With Daratumumab
|
0.152 proportion of participants
Interval 0.063 to 0.289
|
SECONDARY outcome
Timeframe: 1 yearThis will be estimated by the number of patients who achieve MRD negative status by flow cytometry (MPF) in the bone marrow after 1 year of maintenance therapy divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of MRD negative response after 1 year of maintenance will be calculated.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Rate of MRD Negative Response After 1 Year (12 Courses) of Daratumumab and Lenalidomide Maintenance
|
0.3478 proportion of participants
Interval 0.2135 to 0.5025
|
SECONDARY outcome
Timeframe: 3 yearsThe distribution of progression-free survival will be estimated using the Kaplan-Meier method. The percent of patients alive and disease free at 3 years is reported.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
92.6 percent of participants
Interval 84.7 to 100.0
|
SECONDARY outcome
Timeframe: 3 yearsThe distribution of survival time will be estimated using the Kaplan-Meier method. The percent of patients alive at 3 years will be reported.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
97.0 percent of participants
Interval 91.3 to 100.0
|
SECONDARY outcome
Timeframe: 100 daysThis will be estimated by the number of patients with an objective status of stringent complete responses, complete response, very good partial response, or partial response at the day 100 post ASCT assessment divided by the total number of evaluable patients. Response assessment will be in comparison to values obtained at the disease assessment at the time registration. Exact binomial 95% confidence intervals for the true overall response rate at day 100 post ASCT will be calculated.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=46 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
0.7174 proportion of participants
Interval 0.5654 to 0.8401
|
SECONDARY outcome
Timeframe: 3 yearsThe maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percent of patients that reported a grade 3 or higher adverse events according to CTCAE criteria is reported.
Outcome measures
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=49 Participants
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Incidence of Adverse Events
|
90 percent of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to cycle 18/16 months of treatmentMRD assessment will be correlated between blood and bone marrow. Patients will be categorized as positive versus (vs.) negative MRD. The number of patients who have agreement between the 2 measures (both positive or both negative) will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to cycle 18/16 months of treatmentMRD assessment will be correlated between flow cytometry (MPF) and NGS. Patients will be categorized as positive vs. negative MRD for each measure. The number of patients who have agreement between the 2 measures (both positive or both negative) will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to cycle 18/16 months of treatmentThis will be assessed as continuous variables and their mutual change over time as assessed on the pre-specified time points will be correlated with response category to the treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to cycle 18/16 months of treatmentThese will be assessed as continuous variables and their mutual change over time as assessed on the pre-specified time points will be correlated with response category to the treatment.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Daratumumab, ASCT, Lenalidomide)
Serious events: 13 serious events
Other events: 47 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=49 participants at risk
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
8.2%
4/49 • Number of events 4 • 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
4.1%
2/49 • Number of events 2 • 3 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Infections and infestations
Lung infection
|
6.1%
3/49 • Number of events 3 • 3 years
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Infections and infestations
Sinusitis
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Investigations
Platelet count decreased
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Investigations
White blood cell decreased
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
2.0%
1/49 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Treatment (Daratumumab, ASCT, Lenalidomide)
n=49 participants at risk
Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
91.8%
45/49 • Number of events 311 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/49 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
General disorders
Edema limbs
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
51.0%
25/49 • Number of events 231 • 3 years
|
|
General disorders
Injection site reaction
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Infections and infestations
Sinusitis
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.3%
8/49 • Number of events 13 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
65.3%
32/49 • Number of events 67 • 3 years
|
|
Investigations
Lymphocyte count increased
|
2.0%
1/49 • Number of events 1 • 3 years
|
|
Investigations
Neutrophil count decreased
|
83.7%
41/49 • Number of events 185 • 3 years
|
|
Investigations
Platelet count decreased
|
93.9%
46/49 • Number of events 229 • 3 years
|
|
Investigations
White blood cell decreased
|
83.7%
41/49 • Number of events 55 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Number of events 4 • 3 years
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/49 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.5%
12/49 • Number of events 47 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.0%
1/49 • Number of events 2 • 3 years
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Number of events 10 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place