A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Part of paid clinical trials in Stanford, California.

Sponsor
AbbVie
Study ID
NCT05308654
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • ABBV-453 — DRUG
    Oral; Tablet
  • Dexamethasone — DRUG
    Oral Tablet
  • Daratumumab — DRUG
    Subcutaneous Injection
  • Lenalidomide — DRUG
    Oral Capsule

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 ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2, participants are placed in 1 of 3 groups called treatment arms. Each group receives a different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites worldwide. In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and oral dexamethasone tablets once weekly, 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, and side effects.

Key Dates

Start date
May 17, 2022
Status verified
Aug 2025
Primary completion
Feb 7, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Monotherapy Dose Escalation
    Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined.
  • Experimental: Part 2: Arm 1
    Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles.
  • Experimental: Part 2: Arm 2
    Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles.
  • Experimental: Part 2: Arm 3
    Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles.
  • Experimental: Japan Cohort
    Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined.

Primary Outcome Measure

Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) Criteria [ Time Frame: Up to Approximately 12 Months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Stanford University School of Med /ID# 242809StanfordCalifornia94305-2200-
Sylvester Comprehensive Cancer Center /ID# 243417MiamiFlorida33136-1002-
Tulane University School of Medicine /ID# 244854New OrleansLouisiana70112-
American Oncology Partners of Maryland /ID# 244858BethesdaMaryland20817-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754Ann ArborMichigan48109-
Mayo Clinic - Rochester /ID# 242844RochesterMinnesota55905-0001-
Memorial Sloan Kettering Cancer Center /ID# 243503New YorkNew York10065-6007-
Atrium Health Levine Cancer Institute /ID# 243420CharlotteNorth Carolina28204-2990-
Duke Univ Med Ctr /ID# 242808DurhamNorth Carolina27710-
Wake Forest Baptist Health /ID# 244252Winston-SalemNorth Carolina27157-0001-
University of Pennsylvania /ID# 242842PhiladelphiaPennsylvania19104-5502-
Vanderbilt Ingram Cancer Center /ID# 242810NashvilleTennessee37232-0021-

Find similar trials in Stanford, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Stanford University School of Med· Stanford, CASylvester Comprehensive Cancer Center· Miami, FLTulane University School of Medicine· New Orleans, LAAmerican Oncology Partners of Maryland· Bethesda, MDUniversity of Michigan Comprehensive Cancer Center Michigan Medicine· Ann Arbor, MIMayo Clinic - Rochester· Rochester, MN

Related Studies