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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)

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will rec

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 naรฏve. * t(11;14) positive status and/or BCL2 high status. * Must have confirmed diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen, based on the investigator's determination of the international myeloma working group (IMWG) 2016 criteria. Exclusion Criteria: * Major surgery within 4 weeks of study treatment or planned during study participation. * Recent infection requiring systemic treatment that was completed \<= 14 days before first dose of study treatment and/or uncontrolled active systemic infection.
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What it tests

  • Surzetoclax
  • Daratumumab
  • Dexamethasone
  • Pomalidomide
  • Etentamig
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Where

51 sites
University of Southern California /ID# 272414
Los Angeles, United States
Yale University School of Medicine /ID# 272447
New Haven, United States
Dana-Farber Cancer Institute /ID# 271846
Boston, United States
University of Michigan Health System - Ann Arbor /ID# 271536
Ann Arbor, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, United States
Atrium Health Levine Cancer Institute /ID# 271510
Charlotte, United States
University Of North Carolina Health Care - Hillsborough Campus /ID# 272454
Hillsborough, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 271294
Winston-Salem, United States

โ€ฆand 43 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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