A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
AbbVie
Study ID
NCT05259839
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etentamig — DRUG
    Intravenous (IV) Infusion
  • Dexamethasone — DRUG
    Oral; Tablet or IV Infusion
  • Lenalidomide — DRUG
    Oral; Capsule
  • Pomalidomide — DRUG
    Oral; Capsule
  • Daratumumab — DRUG
    Subcutaneous Injection (SC)

Study Details

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 etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Etentamig co-administered with Pd, Rd, or Dd, 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 etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide. Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key Dates

Start date
Oct 20, 2022
Status verified
Dec 2025
Primary completion
Sep 30, 2033
Completion
Sep 30, 2033

Study Design

Enrollment
283 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)
    Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
  • Experimental: Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)
    Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
  • Experimental: Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)
    Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
  • Experimental: Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)
    Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig [ Time Frame: Up to approximately 28 Days ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical Sciences /ID# 243096Little RockArkansas72205-
Sylvester Comprehensive Cancer Center /ID# 243673MiamiFlorida33136-1002-
Moffitt Cancer Center /ID# 243437TampaFlorida33612-9416-
University of Maryland, Baltimore /ID# 243679BaltimoreMaryland21201-
Dana-Farber Cancer Institute /ID# 249529BostonMassachusetts02215-
University of Massachusetts - Worcester /ID# 243977WorcesterMassachusetts01655-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438Ann ArborMichigan48109-
The Valley Hospital /ID# 243829ParamusNew Jersey07652-
Memorial Sloan Kettering Cancer Center /ID# 244656New YorkNew York10065-6007-
Rutenberg Cancer Center /ID# 244647New YorkNew York10029-6030-
Atrium Health Levine Cancer Institute /ID# 242851CharlotteNorth Carolina28204-
University of Texas Southwestern Medical Center /ID# 243273DallasTexas75390-7208-
Huntsman Cancer Institute /ID# 242872Salt Lake CityUtah84112-5500-
University of Washington /ID# 243172SeattleWashington98109-
Froedtert Memorial Lutheran Hospital /ID# 242654MilwaukeeWisconsin53226-3522-

Find similar trials in Little Rock, AR

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Arkansas for Medical Sciences· Little Rock, ARSylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FLUniversity of Maryland, Baltimore· Baltimore, MDDana-Farber Cancer Institute· Boston, MAUniversity of Massachusetts - Worcester· Worcester, MA

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