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A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma


Description

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 toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R M

Trial Eligibility

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Must have confirmed diagnosis of Relapsed/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) criteria. * Must have measurable disease as outlined in the protocol. * Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded. * Has received prior MM treatment in Arms A, B, C, and D. Exclusion Criteria: * Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment. * Unresolved adverse event (AE)s \>= Grade 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from prior anticancer therapy. * Known central nervous system involvement Multiple Myeloma (MM). * Has any of the following conditions: * Nonsecretory MM. * Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential. * Waldenstrom's macroglobulinemia. * Light chain amyloidosis. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome. * Major surgery within 4 weeks prior to first dose or planned study participation. * Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral). * Uncontrolled diabetes or hypertension within 14 days prior to first dose. * Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose. * Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

Study Info

Organization

TeneoOne Inc.


Primary Outcome

Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383


Outcome Timeframe Up to approximately 28 Days

NCTID NCT05259839

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2022-10-20

Completion Date 2028-11-29

Enrollment Target 270

Interventions

DRUG ABBV-383

DRUG Dexamethasone

DRUG Lenalidomide

DRUG Pomalidomide

DRUG Nirogacestat

DRUG Daratumumab

Locations Recruiting

University of Arkansas for Medical Sciences /ID# 243096

United States, Arkansas, Little Rock


Sylvester Comprehensive Cancer Center /ID# 243673

United States, Florida, Miami


Moffitt Cancer Center /ID# 243437

United States, Florida, Tampa


University of Maryland Medical Center /ID# 243679

United States, Maryland, Baltimore


Dana-Farber Cancer Institute /ID# 249529

United States, Massachusetts, Boston


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