Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Running, not enrolling · Phase 2

Conditions studied: Plasma Cell Myeloma, Secondary Amyloidosis

In brief

This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.

Key facts

Study ID: NCT03346135
Run by: City of Hope Medical Center
People needed: 31
Starts: 2019-07-17
Expected to finish: 2027-05-17
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All subjects must have the ability to understand and the willingness to sign a written informed consent
Histologically confirmed diagnosis of multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible)
Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-13 months of the first dose of initial therapy
Eastern Cooperative Oncology Group (ECOG) =< 2
Patients with planned standard of care ASCT using melphalan 200 mg/m\^2; dose modifications in accordance with creatinine clearance levels are allowed per physician judgment
Adequate organ function for high dose chemotherapy and autologous stem cell transplant (as per institution standard operating procedure [SOP])
Adequate cell dose > 2.5 x 10\^6 CD34+ cells/kg
Absolute neutrophil count (ANC) >= 1000/mm\^3
Platelet count >= 75,000/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
Total bilirubin =< 1.5 x the upper limit of normal (ULN)
Aspartate aminotransferase (AST) =< 3 x ULN
Alanine aminotransferase (ALT) =< 3 x ULN
Calculated creatinine clearance >= 30 mL/min
Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of daratumumab for women)
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

You may not qualify if…

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)

Where it is running

City of Hope Medical Center — Duarte, California, United States
Sarah Cannon Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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