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Daratumumab in Treating Patients with Relapsed Multiple Myeloma after Stem Cell Transplant

Trial Status: Active

This phase II trial studies how well daratumumab works in treating patients with multiple myeloma that has come back (relapsed) after stem cell transplant. Immunotherapy with daratumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread.

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 120 days post autologous stem cell transplantation (ASCT)
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Platelet count >= 50,000/mm^3 (within 5 days before the first dose of the study drug)
  • Absolute neutrophil count >= 1000/ mm^3 (no growth factors within 5 days) (within 5 days before the first dose of the study drug)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (within 5 days before the first dose of the study drug)
  • Creatinine =< 2.5 mg/dL (within 5 days before the first dose of the study drug)
  • Recovered (i.e., =< grade 2 toxicity) from the reversible effects of autologous stem cell transplant (within 5 days before the first dose of the study drug)
  • 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study-related procedure not part of normal medical care must be obtained, with the understanding that consent may be withdrawn by the subject at any time without any prejudice to future medical care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%. No uncontrolled arrhythmias

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
  • Already achieved CR at time of enrollment
  • 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)
  • Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume in 1 second (FEV1) less than 60% of expected
  • Infection requiring IV systemic antibiotic therapy within 7 days before cycle 1 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
  • 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 in the past

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Muzaffar H. Qazilbash
Phone: 713-792-2466

PRIMARY OBJECTIVE:

I. To estimate the complete remission rate (CRR) by the International Myeloma Working Group (IMWG) criteria within 9 months post salvage auto-transplant with daratumumab maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.

SECONDARY OBJECTIVE:

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

EXPLORATORY OBJECTIVE:

I. To discover the impact of daratumumab on graft function and immune reconstitution.

OUTLINE:

Beginning 60-120 days after transplant, patients receive daratumumab intravenously (IV) over 4-8 hours on days 1, 8, 15 and 22 of cycles 1 and 2 and days 1 and 15 of cycles 3-6, then on day 1 of subsequent cycles. Cycles repeat every 28 days for 2 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 4-12 weeks thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Muzaffar H. Qazilbash

  • Primary ID 2016-0681
  • Secondary IDs NCI-2018-01432
  • Clinicaltrials.gov ID NCT03622775