Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant
- Conditions
- Recurrent Plasma Cell Myeloma
- Registration Number
- NCT03622775
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patient must have had relapsed disease prior to transplant, or undergone previous<br> autologous stem cell transplant (ASCT), followed by relapse and at least a partial<br> response to salvage therapy<br><br> - Eligible patients will be enrolled in the protocol no less than 60 days and must be<br> initiated no longer than 180 (+/- 14) days post autologous stem cell transplantation<br> (ASCT)<br><br> - Male or female patients 18 years or older.<br><br> - Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2<br><br> - Patients' clinical laboratory values and toxicity must be as specified below within<br> 14 days before the first dose of the study drug:<br><br> - Platelet count >= 50,000/mm^3<br><br> - Absolute neutrophil count >= 1000/ mm^3 (no growth factors within 5 days)<br><br> - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x<br> upper limit of normal (ULN)<br><br> - Creatinine <= 2.5 mg/dL<br><br> - Recovered (i.e., =< grade 2 toxicity) from the reversible effects of autologous<br> stem cell transplant<br><br> - Voluntary written informed consent before performance of any study-related procedure<br> not part of normal medical care must be obtained, with the understanding that<br> consent may be withdrawn by the subject at any time without any prejudice to future<br> medical care<br><br> - Left ventricular ejection fraction >/=40% at the patient's last recorded<br> echocardiogram (this could refer to pretransplant ECHO. ECHO may be repeated if the<br> PI considers a repeat ECHO). No uncontrolled arrythmias.<br><br>Exclusion Criteria:<br><br> - Major surgery within 14 days before the first dose of study drug<br><br> - Radiotherapy within 14 days before enrollment<br><br> - Non-secretory disease, plasma cell leukemia, or previous allogeneic transplant<br><br> - Known active central nervous system involvement<br><br> - Inability or unwillingness to comply with the drug administration requirements<br><br> - Female subject is pregnant or lactating<br><br> - Seropositive for human immunodeficiency virus (HIV)<br><br> - Seropositive for hepatitis B (defined by a positive test for hepatitis B surface<br> antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg<br> negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or<br> antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using<br> real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV)<br> deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.<br> EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs<br> positivity as the only serologic marker) AND a known history of prior HBV<br> vaccination, do not need to be tested for HBV DNA by PCR<br><br> - Seropositive for hepatitis C (except in the setting of a sustained virologic<br> response [SVR], defined as aviremia at least 12 weeks after completion of antiviral<br> therapy)<br><br> - Patients with a known history of asthma or chronic obstructive pulmonary disease<br> with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal.<br><br> - Patients with moderate or severe persistent asthma within the past 2 years and<br> currently uncontrolled asthma of any classification.<br><br> - Infection requiring IV systemic antibiotic therapy within 7 days before cycle day 1<br> (C1D1) of therapy<br><br> - Known allergy to any of the study medications, their analogues, or excipients in the<br> various formulations<br><br> - Failure to have fully recovered (i.e., <= grade 2 toxicity) from the effects of<br> prior chemotherapy regardless of the interval since last treatment<br><br> - Patient is refractory or resistant to daratumumab and pomalidomide<br><br> - Co-morbid systemic illnesses or other severe concurrent disease that, in the<br> judgment of the investigator, would make the patient inappropriate for entry into<br> this study or interfere significantly with the proper assessment of safety and<br> toxicity of the prescribed regimens<br><br> - If patient was unable to tolerate daratumumab or pomalidomide in the past
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete remission rate (CRR) defined as achieving a negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow;Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method