OncoMatch/Clinical Trials/NCT05922501
Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma
Is NCT05922501 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Isatuximab and Belantamab mafodotin for relapsed cancer.
Treatment: Isatuximab · Belantamab mafodotin · Pomalidomide · Dexamethasone — The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: lenalidomide (lenalidomide)
Prior therapy must include at least 2 cycles of lenalidomide
Must have received: proteasome inhibitor
at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
Cannot have received: anti-CD38 monoclonal antibody
Exception: within six months
Prior therapy with anti-CD38 monoclonal antibody within six months
Cannot have received: multiple myeloma monoclonal antibody therapy
Exception: within 30 days of start of study treatment
No other multiple myeloma monoclonal antibody therapy within 30 days of start of study treatment
Cannot have received: anti-BCMA therapy
Prior therapy with anti-BCMA therapy
Cannot have received: allogeneic stem cell transplant
Exception: <12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease (GVHD).
Allogeneic stem cell transplant <12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease (GVHD).
Cannot have received: autologous stem cell transplant
Exception: <6 months prior to start of treatment
Autologous stem cell transplant <6 months prior to start of treatment
Cannot have received: plasmapheresis
Exception: within seven days prior to start of study treatment
Plasmapheresis within seven days prior to start of study treatment
Lab requirements
Blood counts
ANC ≥ 1000/μL (no G-CSF within 14 days of screening; exceptions possible with PI approval); Platelet count ≥ 75,000/μL (no platelet transfusion within 7 days of screening); Hemoglobin ≥ 8 g/dL (RBC transfusions permitted)
Kidney function
Calculated creatinine clearance of ≥ 30 mL/min by MDRD or Cockcroft-Gault formula; Spot urine (albumin/creatinine ratios < 500 mg/g or urine dipstick negative/trace)
Liver function
Serum bilirubin values < 1.5 × ULN (exceptions for Gilbert's syndrome); ALT and/or AST values < 2.5 × ULN
ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening. Patients with ANC <1000/µL can be considered for screening on a case-by-case basis with additional monitoring, after discussion with and approval from the PI. Platelet count ≥ 75,000/µL. Platelet transfusion is not permitted within 7 days of screening. Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria. Calculated creatinine clearance of ≥ 30 mL/min by MDRD or Cockcroft-Gault formula. Spot urine (albumin/creatinine ratios < 500 mg/g or urine dipstick negative/trace). Patient has adequate hepatic function, as evidenced by each of the following: Serum bilirubin values < 1.5 × ULN. Isolated bilirubin ≥ 1.5 × ULN is acceptable if bilirubin is fractionated and direction bilirubin <35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin <3 mg/dL and normal direct bilirubin); and Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values < 2.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
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