Isatuximab Bendamustine and Prednisone in Refractory Multiple Myeloma

  • End date
    Oct 28, 2028
  • participants needed
  • sponsor
    Washington University School of Medicine
Updated on 12 April 2021
monoclonal antibodies
measurable disease
bone marrow procedure
neutrophil count
monoclonal protein
bone pain
proteasome inhibitor
refractory multiple myeloma
bone marrow plasma cells


Isatuximab targets and kills CD38-positive myeloma cells in manner similar to rituximab's mechanism of action on CD20-positive lymphoma cells. Based on the synergy between rituximab and bendamustine, as well as the established clinical efficacy of bendamustine and isatuximab as single agents for multiple myeloma, the logical next step is to combine isatuximab with bendamustine and prednisone. Due to lack of effective therapies in refractory multiple myeloma, herein the investigators propose studying this novel combination in this population, in order to address a significant unmet need. The aim of the investigators is to first determine the maximal tolerated dose of the combination in participants with relapsed/refractory myeloma and then to establish the efficacy of this novel combination.

Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment prednisone, Bendamustine, Isatuximab
Clinical Study IdentifierNCT04083898
SponsorWashington University School of Medicine
Last Modified on12 April 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of multiple myeloma with a measurable disease parameter at time of screening. A measurable disease parameter is defined as one or more of the following
Serum monoclonal protein 0.5 g/dL
hour urine monoclonal protein 200 mg/24 hour
Serum free light chain ratio > 5x normal ratio with an absolute difference of 10mg/dL between the involved and uninvolved free light chain
Soft tissue plasmacytoma 2 cm measurable by either physical examination and/or applicable radiographs (e.g. MRI, CT, etc.)
Bone marrow plasma cells 30%
Triple-class-refractory disease defined as both of the following
Previously received treatment with a proteasome inhibitor, an immunomodulatory drug, and daratumumab, in combination or as single-agents
Refractory (defined per IMWG Consensus Criteria as disease that is nonresponsive while on therapy, or progresses within 60 days of last dose) to most recent therapy
At least 6 weeks from the last treatment with daratumumab to the first study treatment
At least 18 years of age
Performance status of ECOG 2 Note: Participants with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible
Normal bone marrow and organ function as defined as ALL of the following
Absolute neutrophil count 1500/mm3
Platelets 75,000 (transfusions not permitted within 7 days of screening)
ALT (SGPT) and AST (SGOT) < 3.5 x the upper limit of the institutional normal value (ULN)
Total bilirubin 2.0 x mg/dL
Creatinine clearance > 30 ml/min using Cockcroft-Gault formula
Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant while on study drug and for 3 months after discontinuation from study drug, and must agree to use adequate contraception including hormonal contraception, (e.g. birth control pills, etc.), barrier method contraception (e.g. condoms), or abstinence during that time frame. Men engaging in sexual intercourse with a FCBP must agree to use adequate contraception including hormonal contraception, (e.g. birth control pills, etc), barrier method contraception (e.g. condoms), or abstinence while on study drug and for 3 months after discontinuation from study drug
Ability to understand and willing to sign a written informed consent document

Exclusion Criteria

Prior exposure to isatuximab or bendamustine
History of plasma cell leukemia or MM CNS involvement
Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis
Diagnosed with another concurrent malignancy requiring treatment
Active hepatitis A, B, or C
Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of study therapy
Receiving any other investigational agents within 14 days prior to enrollment
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry
Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended
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