Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Exclusion Criteria

• •Prior disease progression with daratumumab or other anti-CD38 antibody
• •History of organ or previous autologous/allogeneic stem cell transplantation
• •Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance
• •Female patients who are lactating or have a positive pregnancy test during the screening period
• •Evidence of multiple myeloma (MM) disease progression any time prior to enrollment; progression from smoldering to active myeloma is not exclusionary
• •History of plasma cell leukemia or central nervous system (CNS) involvement
• •Major surgery within 14 days prior to start of study treatment
• •Infection requiring systemic antibiotic therapy within 14 days prior to the start of study treatment
• •Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
• •Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
• •Subject is currently using or has used immunosuppressive medication within 14 days prior to the first dose of study treatment; the following are exceptions:
• •* Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
• •* Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
• •* Steroids as premedication for hypersensitivity reaction (e.g., infusion-related reactions, computed tomography \[CT\] scan premedication)
• •Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
• •Subjects with uncontrolled, systematic infection should be excluded
• •Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% predicted normal; Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 \< 50%
• •Subject has known moderate or severe persistent asthma within 2 years, or currently has uncontrolled asthma of any classification; (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
• •Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., Crohn's disease\], diverticulitis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis, etc) within the past 3 years prior to the start of treatment; the following are exceptions:
• •* Subjects with vitiligo or alopecia
• •* Subjects with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
• •* Psoriasis not requiring systemic treatment
• •Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients
• •Subject has history of primary immunodeficiency
• •Subject is seropositive for human immunodeficiency virus (HIV-1)
• •Active hepatitis A
• •Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]); subjects with resolved infection (I.e., 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 finding 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)
• •Subject has any one of the following:
• •* Clinically significant abnormal electrocardiogram (ECG) finding at screening
• •* Congestive heart failure (New York Heart Association class III or IV)
• •* Myocardial infarction within 12 months prior to starting study treatment
• •* Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
• •Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for \>= 5 years with the exception of the following malignancies:
• •* Basal cell carcinoma of the skin
• •* Squamous cell carcinoma of the skin
• •* Carcinoma in situ of the cervix
• •* Carcinoma in situ of the breast
• •* Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \[TNM\] clinical staging system) or prostate cancer that is curative
• •Any other condition that would, in the opinion of the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)