Phase 2
Completed N=49
Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma
Plasma Cell Myeloma
Source: ClinicalTrials.gov NCT03477539 ↗
Enrolled (actual)
49
Serious AEs
26.5%
Results posted
Mar 2026
Primary outcomePrimary: Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT) — 0.652 proportion of participants
Summary
This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Minimal Residual Disease (MRD) Negative Response After Autologous Stem Cell Transplantation (ASCT) |
0.652 | — |
| SECONDARY The Rate of MRD Negative Response After Pre-stem Cell Transplant (SCT) Consolidation With Daratumumab |
0.152 | — |
| SECONDARY Rate of MRD Negative Response After 1 Year (12 Courses) of Daratumumab and Lenalidomide Maintenance |
0.3478 | — |
| SECONDARY Progression-free Survival |
92.6 | — |
| SECONDARY Overall Survival |
97.0 | — |
| SECONDARY Overall Response Rate |
0.7174 | — |
| SECONDARY Incidence of Adverse Events |
90 | — |
Eligibility Criteria
Inclusion Criteria
- Considered transplant eligible
- Pathologically confirmed diagnosis of multiple myeloma who are transplant eligible and have received any prior induction therapy (with or without maintenance)
- Measurable MRD in bone marrow within 28 days prior to registration (MPF method)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 at registration
- Absolute neutrophil count (ANC) >= 1, 000 cell/mm^3 without growth factor support, obtained = = 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis = 30,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50%, obtained = = 30 ml/min, obtained = = grade 3 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Other prior malignancy
- Exceptions:
- Adequately treated basal cell or squamous cell skin cancer
- Any in situ cancer
- Adequately treated stage I or II cancer from which the patient is currently in complete remission, or
- Any other cancer from which the patient has been disease free for at least 3 years
- Concurrent therapy considered investigational
- NOTE: patients must not be planning to receive any radiation therapy (except localized radiation for palliative care that must be completed prior to starting cycle 1, day 1)
- Pregnant women
- Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide)
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Major surgery = = grade 3 cardiac arrhythmias noted =< 14 days prior to registration
- Known human immunodeficiency virus positive (HIV+) patients
- Known hepatitis B or hepatitis C infection
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
- Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume (FEV1) in 1 second less than < 60% of expected
Data sourced from ClinicalTrials.gov (NCT03477539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.