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 (NCT05308654)
First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford University School of Med /ID# 242809 — Stanford, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Stanford University School of Med /ID# 242809 — Stanford, California
- Sylvester Comprehensive Cancer Center /ID# 243417 — Miami, Florida
- Tulane University School of Medicine /ID# 244854 — New Orleans, Louisiana
- American Oncology Partners of Maryland /ID# 244858 — Bethesda, Maryland
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754 — Ann Arbor, Michigan
- Mayo Clinic - Rochester /ID# 242844 — Rochester, Minnesota
- Memorial Sloan Kettering Cancer Center /ID# 243503 — New York, New York
- Atrium Health Levine Cancer Institute /ID# 243420 — Charlotte, North Carolina
- Duke Univ Med Ctr /ID# 242808 — Durham, North Carolina
- Wake Forest Baptist Health /ID# 244252 — Winston-Salem, North Carolina
- University of Pennsylvania /ID# 242842 — Philadelphia, Pennsylvania
- Vanderbilt Ingram Cancer Center /ID# 242810 — Nashville, Tennessee
- Liverpool Hospital /ID# 244826 — Liverpool, New South Wales
- St. Vincent's Private Hospital Melbourne /ID# 262631 — Fitzroy, Victoria
- St Vincent's Hospital Melbourne /ID# 244827 — Fitzroy Melbourne, Victoria
- Austin Health and Ludwig Institute for Cancer Research /ID# 248311 — Heidelberg, Victoria
- Epworth Healthcare /ID# 248705 — Richmond, Victoria
- Hadassah Medical Center-Hebrew University /ID# 250484 — Jerusalem, Jerusalem
- The Chaim Sheba Medical Center /ID# 250482 — Ramat Gan, Tel Aviv
- Tel Aviv Sourasky Medical Center /ID# 250483 — Tel Aviv, Tel Aviv
- Barts Health NHS Trust /ID# 248972 — London, London, City of
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Relapsed/Refractory Multiple Myeloma
- 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 — Little Rock, Arkansas
- Cevostamab Following CAR T Cell Therapy for RRMM — Philadelphia, Pennsylvania
- A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma — Clayton, North Carolina
- A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma — Birmingham, Alabama
- CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma — Birmingham, Alabama
Explore by condition: All Relapsed/Refractory Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.