Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma (NCT04896658) | Clinical Trial Compass
TerminatedPhase 1/2
Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
Stopped: The study was terminated due to FDA withdrawal of the drug and lack of enrollment with available BCMA therapies that were deemed safer.
United States10 participantsStarted 2021-12-03
Plain-language summary
Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed diagnosis of Refractory MM; failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody (e.g., daratumumab) alone or in combination, and is refractory to an IMiD (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib). (Refractory myeloma is defined as disease that is nonresponsive while on primary or salvage therapy or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve at least minimal response or development of progressive disease (PD) while on therapy).
✓. Has measurable disease with at least one of the following:
✓. Serum M-protein ≥0.5 g/dL (≥ 5 g/L)
✓. Urine M-protein ≥ 200 mg/24h
✓. Serum FLC assay: Involved FLC level ≥10 mg/dL and an abnormal ratio (\<0.26 or \>1.65)
✓. Provide signed written informed consent.
✓. 18 years or older (at the time consent is obtained).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion criteria
✕. Systemic anti-myeloma therapy within ≤14 days or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to treatment.
✕. Systemic treatment with high dose steroids (equivalent to ≥ 60 mg prednisone daily for ≥4 days) within the past 14 days.
What they're measuring
1
Number of Participants With Adverse Events in Dose Escalation
Timeframe: Up to 6 weeks
2
Response Rate in Dose Escalation and Expansion Cohort
. Symptomatic amyloidosis, active CNS disease, active plasma cell leukemia at the time of screening.
✕. Prior allogeneic stem cell transplant (SCT). NOTE - Participants who have undergone syngeneic transplant may be allowed if no history of GvHD.
✕. Current corneal epithelial disease except mild punctate keratopathy.
✕. Evidence of active bleeding.
✕. Any major surgery within the last four weeks.
✕. Presence of active renal condition (infection, dialysis); isolated proteinuria from MM is allowed provided participants fulfil the adequate organ system function criteria (as defined by inclusion criteria #7).