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Recurrent Plasma Cell MyelomaPhase 2NCT03622775

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

A Phase 2 study testing Daratumumab in people with Recurrent Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Plasma Cell Myeloma
What is being tested?
Daratumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
11 Apr 2019to 9 Oct 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Daratumumab-Based Maintenance in Patients With Relapsed Multiple Myeloma After Salvage Autologous Stem Cell Transplantation

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:

  1. 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:

  1. To evaluate progression-free survival (PFS).

EXPLORATORY OBJECTIVES:

  1. 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.

Being tested
Daratumumab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabBiological

    Also called Anti-CD38 Monoclonal Antibody, Darzalex, HuMax-CD38, JNJ-54767414

    Given IV

Study groups in NCT03622775
Study groupRoleWhat they receive
Treatment (daratumumab)ExperimentalBeginning 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.
Receives: Biological: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 9 months post salvage auto transplant

Secondary outcomes (1)

  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.

    Measured: From the date of initiation of maintenance therapy assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study start11 Apr 2019
  3. Primary completion9 Oct 2025
  4. Study completion9 Oct 2025

Why it stopped: \<75% participation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03622775
Sponsor's protocol ID
2016-0681
Other IDs
NCI-2018-01432, 2016-0681
Status last verified
Apr 2026
First submitted
16 Jul 2018
Last updated
24 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daratumumab in people with Recurrent Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Complete Remission (time frame: Within 9 months post salvage auto transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03622775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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