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NCT05308654 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 20
- Study locations
NCT05308654: Active Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie.
NCT05308654 is a Phase 1 study of Relapsed/Refractory Multiple Myeloma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 34 participants, below the 170-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05308654, a Phase 1 study of Relapsed/Refractory Multiple Myeloma, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG ABBV-453
Study Locations (20)
Victoria
- St. Vincent's Private Hospital Melbourne /ID# 262631 - Fitzroy
- St Vincent's Hospital Melbourne /ID# 244827 - Fitzroy Melbourne
- Austin Health and Ludwig Institute for Cancer Research /ID# 248311 - Heidelberg
- Epworth Healthcare /ID# 248705 - Richmond
North Carolina
- Atrium Health Levine Cancer Institute /ID# 243420 - Charlotte
- Duke Univ Med Ctr /ID# 242808 - Durham
- Wake Forest Baptist Health /ID# 244252 - Winston-Salem
Tel Aviv
- The Chaim Sheba Medical Center /ID# 250482 - Ramat Gan
- Tel Aviv Sourasky Medical Center /ID# 250483 - Tel Aviv
California
- Stanford University School of Med /ID# 242809 - Stanford
Florida
- Sylvester Comprehensive Cancer Center /ID# 243417 - Miami
Louisiana
- Tulane University School of Medicine /ID# 244854 - New Orleans
Maryland
- American Oncology Partners of Maryland /ID# 244858 - Bethesda
Michigan
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT05308654 still lists
NCT05308654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 170-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT05308654 names 20 study sites across 14 states, led by Victoria, North Carolina, Tel Aviv.
Frequently Asked Questions
What is clinical trial NCT05308654 about?
NCT05308654 is a clinical study titled "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". 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...
What is the current status of trial NCT05308654?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2022-05-17. Estimated completion is 2025-12.
What conditions does trial NCT05308654 study?
This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.
What interventions are being tested in trial NCT05308654?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), ABBV-453 (DRUG).
Who is sponsoring clinical trial NCT05308654?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05308654 being conducted?
This trial has 20 study locations across California, Florida, Louisiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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