ClinicaliQ Trial Snapshot
- A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM) — Recruiting • Phase I • Cardiology / Cardiovascular • NCT06953960.
- Being Tested: Surzetoclax, an oral agent, administered alone or combined with established subcutaneous/oral antimyeloma treatments, to evaluate safety profile and disease activity changes in multiple myeloma patients.
- Patient Eligibility: Adult participants with confirmed multiple myeloma diagnosis; specific inclusion/exclusion criteria apply regarding prior treatment history and organ function, though full details require protocol review.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. Surzetoclax is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of surzetoclax in combination with daratumumab +…
Eligibility Snapshot
- : * Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria. * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: * Serum M-protein >= 0.5 g/dL (>= 5g/L); OR * Urine M-protein >= 200 mg/24 hours; OR * For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) ≥ 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal. * B-cell lymphoma (BCL)-2 inhibitor treatment naïve. * t(11;14) positive status and/or BCL2 high status. * Substudy 1 Dose Escalation Cohorts and Substudy 2: -- Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment options as deemed by the investigator. * Substudy 1 Dose Expansion Cohorts: * Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.