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TerminatedNCT03622775Updated Apr 24, 2026Results posted

Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant

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

Why this study was terminated
\<75% participation
Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Recurrent Plasma Cell Myeloma

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03

In context

Multiple Myeloma

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient must have had relapsed disease prior to transplant, or undergone previous autologous stem cell transplant (ASCT), followed by relapse and at least a partial response to salvage therapy
  • Eligible patients will be enrolled in the protocol no less than 60 days and must be initiated no longer than 180 (+/- 14) days post autologous stem cell transplantation (ASCT)
  • Male or female patients 18 years or older.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Patients' clinical laboratory values and toxicity must be as specified below within 14 days before the first dose of the study drug:

    • Platelet count >= 50,000/mm\^3
    • Absolute neutrophil count >= 1000/ mm\^3 (no growth factors within 5 days)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 3 x upper limit of normal (ULN)
    • Creatinine \<= 2.5 mg/dL
    • Recovered (i.e., =\< grade 2 toxicity) from the reversible effects of autologous stem cell transplant
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care must be obtained, with the understanding that consent may be withdrawn by the subject at any time without any prejudice to future medical care
  • Left ventricular ejection fraction >/=40% at the patient's last recorded echocardiogram (this could refer to pretransplant ECHO. ECHO may be repeated if the PI considers a repeat ECHO). No uncontrolled arrythmias.

Exclusion criteria

Exclusion Criteria:

  • Major surgery within 14 days before the first dose of study drug
  • Radiotherapy within 14 days before enrollment
  • Non-secretory disease, plasma cell leukemia, or previous allogeneic transplant
  • Known active central nervous system involvement
  • Inability or unwillingness to comply with the drug administration requirements
  • Female subject is pregnant or lactating
  • Seropositive for human immunodeficiency virus (HIV)
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
  • Patients with a known history of asthma or chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal.
  • Patients with moderate or severe persistent asthma within the past 2 years and currently uncontrolled asthma of any classification.
  • Infection requiring IV systemic antibiotic therapy within 7 days before cycle day 1 (C1D1) of therapy
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations
  • Failure to have fully recovered (i.e., \<= grade 2 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment
  • Patient is refractory or resistant to daratumumab and pomalidomide
  • Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • If patient was unable to tolerate daratumumab or pomalidomide in the past
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Treatment (daratumumab)

    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

Interventions

  • BiologicalDaratumumab

    Given IV

    Also known as: Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Results

Posted Feb 10, 2026

Participant flow

Participant flow — Overall Study
MilestoneMaintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Started13
Completed13
Not completed0

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Complete Remission
ParticipantsMaintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Number of Participants With Complete Remission11
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants That Relapsed With Progression-free Survival (PFS)
ParticipantsMaintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
PFS at 20 months11
PFS at 36 months8
PFS at 60 months7

Adverse events

Collected over Up to 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.2/13 (15.4%)1/13 (7.7%)7/13 (53.8%)
Most frequent serious events
Most frequent serious events
EventMaintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
ALT increasedInvestigations1/13
AST increasedInvestigations1/13
Low granulocyteBlood and lymphatic system disorders1/13
Neutrophil count decreasedInvestigations1/13
Most frequent other events
Showing 10 of 43
Most frequent other events
EventMaintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Neutrophil count decreasedInvestigations7/13
ViralInfections and infestations7/13
FatigueGeneral disorders6/13
DiarrheaGastrointestinal disorders5/13
Low granulocyteBlood and lymphatic system disorders5/13
Low plateletInvestigations5/13
ALT increasedInvestigations4/13
BacterialInfections and infestations4/13
EdemaGeneral disorders4/13
AnemiaInvestigations3/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
<=18 years0
Between 18 and 65 years7
>=65 years6
Sex: Female, Male
Sex: Female, Male(Participants)Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Female6
Male7
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
Hispanic or Latino0
Not Hispanic or Latino13
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Maintenance Therapy With Daratumumab/Hyaluronidase-fihj/Pomalidomide Post ASCT in MM Patients.
United States13
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 23, 2025
  • Informed consent form · Jan 23, 2025

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03622775
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
Janssen Scientific Affairs, LLC
Responsible party
Sponsor
First posted
Aug 9, 2018
Start date
Apr 11, 2019
Primary completion
Oct 9, 2025
Completion
Oct 9, 2025
Results posted
Feb 10, 2026
Last update
Apr 24, 2026

Study contacts

Muzaffar H Qazilbash
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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