Trial Outcomes & Findings for Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant (NCT NCT03622775)
NCT ID: NCT03622775
Last Updated: 2026-04-24
Results Overview
Number of participants that achieved Complete remission (CR) 9 months post auto transplant. Complete remission (CR) (all of the following): 1. Negative immunofixation in serum and urine. 2. \< 5% plasma cells in the bone marrow. 3. Disappearance of any soft tissue plasmacytomas.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Within 9 months post salvage auto transplant
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide.
Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression.
Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
n=13 Participants
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide.
Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression.
Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Within 9 months post salvage auto transplantNumber of participants that achieved Complete remission (CR) 9 months post auto transplant. Complete remission (CR) (all of the following): 1. Negative immunofixation in serum and urine. 2. \< 5% plasma cells in the bone marrow. 3. Disappearance of any soft tissue plasmacytomas.
Outcome measures
| Measure |
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
n=13 Participants
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide.
Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression.
Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
|
|---|---|
|
Number of Participants With Complete Remission
|
11 Participants
|
SECONDARY outcome
Timeframe: From the date of initiation of maintenance therapy assessed up to 5 yearsProgression-free survival is defined as the interval from the date of initiation of maintenance therapy after salvage ASCT to the earlier of the first documentation of objective disease progression or death from any cause.
Outcome measures
| Measure |
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
n=13 Participants
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide.
Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression.
Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
|
|---|---|
|
Number of Participants That Relapsed With Progression-free Survival (PFS)
PFS at 20 months
|
11 Participants
|
|
Number of Participants That Relapsed With Progression-free Survival (PFS)
PFS at 36 months
|
8 Participants
|
|
Number of Participants That Relapsed With Progression-free Survival (PFS)
PFS at 60 months
|
7 Participants
|
Adverse Events
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Serious events: 1 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
n=13 participants at risk
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide.
Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression.
Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
|
|---|---|
|
Investigations
ALT increased
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Investigations
AST increased
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Low granulocyte
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
Other adverse events
| Measure |
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
n=13 participants at risk
Beginning 60 days to 180 (+/- 14) days post ASCT, patients with relapsed multiple myeloma prior to transplant, or undergone previous ASCT, followed by relapse and at least a partial response to salvage therapy will receive maintenance therapy with daratumumab/hyaluronidase-fihj and pomalidomide.
Daratumumab 1800 mg/hyaluronidase-fihj 30,000 units will be given SC weekly for weeks 1-8, followed by every 2 weeks for weeks 9-24, and then every month for weeks 25 until progression.
Pomalidomide will be given at 2 mg PO daily from day 1-21 in the 28-day cycle for up to 4 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
3/13 • Number of events 3 • Up to 2 years
|
|
Investigations
T bilirubin increased
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Viral
|
53.8%
7/13 • Number of events 20 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Investigations
Wbc decreased
|
15.4%
2/13 • Number of events 3 • Up to 2 years
|
|
Investigations
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Investigations
ALK increased
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Investigations
ALT increased
|
30.8%
4/13 • Number of events 4 • Up to 2 years
|
|
Investigations
Anemia
|
23.1%
3/13 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Investigations
AST increased
|
15.4%
2/13 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Bacterial
|
30.8%
4/13 • Number of events 5 • Up to 2 years
|
|
Gastrointestinal disorders
Bacterial
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
15.4%
2/13 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Chest pain
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
38.5%
5/13 • Number of events 7 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema
|
30.8%
4/13 • Number of events 5 • Up to 2 years
|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 11 • Up to 2 years
|
|
Immune system disorders
Hypogammaglobulinemia
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
23.1%
3/13 • Number of events 5 • Up to 2 years
|
|
Investigations
LDH increased
|
15.4%
2/13 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Low granulocyte
|
38.5%
5/13 • Number of events 11 • Up to 2 years
|
|
Investigations
Low platelet
|
38.5%
5/13 • Number of events 9 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.4%
2/13 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 3 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
53.8%
7/13 • Number of events 49 • Up to 2 years
|
|
Renal and urinary disorders
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
|
7.7%
1/13 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Peripheral neuropathy
|
7.7%
1/13 • Number of events 1 • Up to 2 years
|
Additional Information
Muzaffar Qazilbash, MD/ Stem Cell Transplantation Department
University of Texas MD Anderson Cancer Center
Phone: 713-745-3459
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place