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

NCT03622775 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2016-0681NCI-2018-01432
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Plasma Cell Myeloma

Outcome Measures

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.

  Within 9 months post salvage auto transplant

Secondary Outcomes (1)

• Number of Participants That Relapsed With Progression-free Survival (PFS)

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

Study Arms (1)

Treatment (daratumumab)

EXPERIMENTAL

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

Daratumumab BIOLOGICAL

Given IV

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

Treatment (daratumumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Muzaffar Qazilbash, MD/ Stem Cell Transplantation Department
• Organization: University of Texas MD Anderson Cancer Center

mqazilba@mdanderson.org

713-745-3459

Study Officials

• Muzaffar H Qazilbash

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 9, 2018
• Study Start: April 11, 2019
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: April 24, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-04

Locations

US (1)