A Phase 2 interventional study of Daratumumab in Recurrent Plasma Cell Myeloma, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies whether daratumumab and hyaluronidase-fihj and pomalidomide work in treating patients with multiple myeloma that has come back (relapsed) after stem cell transplant. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab and hyaluronidase-fihj with pomalidomide may help control the disease in patients with relapsed multiple myeloma.
PRIMARY OBJECTIVES:
I. To estimate the complete remission rate (CRR) by the International Myeloma Working Group (IMWG) criteria within 9 months post salvage auto-transplant with subcutaneous daratumumab and hyaluronidase-fihj plus pomalidomide maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.
SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS).
EXPLORATORY OBJECTIVES:
I. To discover the impact of daratumumab and hyaluronidase-fihj plus pomalidomide on graft function and immune reconstitution.
OUTLINE:
Beginning 60-180 days after transplant, patients daratumumab and hyaluronidase-fihj subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1 and 2, on days 1 and 15 of cycles 3-6, and then on day 1 of subsequent cycles. Patients also receive pomalidomide orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 90 days, then every 12 weeks thereafter.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients' clinical laboratory values and toxicity must be as specified below within 14 days before the first dose of the study drug:
Exclusion Criteria:
Beginning 60-120 days after transplant, participants receive daratumumab IV over 4-8 hours on days 1, 8, 15 and 22 of courses 1 and 2 and days 1 and 15 of courses 3-6, then on day 1 of subsequent courses. Courses repeat every 28 days for 3 years in the absence of disease progression or unacceptable toxicity.
Biological: Daratumumab
Given IV
Also known as: Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414
Number of Participants With Complete Remission
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.
Time frame: Within 9 months post salvage auto transplant
Number of Participants That Relapsed With Progression-free Survival (PFS)
Progression-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.
Time frame: From the date of initiation of maintenance therapy assessed up to 5 years
| Milestone | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
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.
| Participants | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| Number of Participants With Complete Remission | 11 |
Progression-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.
| Participants | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| PFS at 20 months | 11 |
| PFS at 36 months | 8 |
| PFS at 60 months | 7 |
Collected over Up to 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. | 2/13 (15.4%) | 1/13 (7.7%) | 7/13 (53.8%) |
| Event | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| ALT increasedInvestigations | 1/13 |
| AST increasedInvestigations | 1/13 |
| Low granulocyteBlood and lymphatic system disorders | 1/13 |
| Neutrophil count decreasedInvestigations | 1/13 |
| Event | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| Neutrophil count decreasedInvestigations | 7/13 |
| ViralInfections and infestations | 7/13 |
| FatigueGeneral disorders | 6/13 |
| DiarrheaGastrointestinal disorders | 5/13 |
| Low granulocyteBlood and lymphatic system disorders | 5/13 |
| Low plateletInvestigations | 5/13 |
| ALT increasedInvestigations | 4/13 |
| BacterialInfections and infestations | 4/13 |
| EdemaGeneral disorders | 4/13 |
| AnemiaInvestigations | 3/13 |
| Age, Categorical(Participants) | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 6 |
| Sex: Female, Male(Participants) | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| Female | 6 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients. |
|---|---|
| United States | 13 |
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M.D. Anderson Cancer Center