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A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
NCT06953960 · View on ClinicalTrials.gov ↗
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 change in disease activity 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. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase). In Substudy 2, there will be a dose escalation phase where participants will receive various doses of ABBV-453 alone. Approximately 130 adult participants with R/R MM will be enrolled in the study in approximately 40 sites worldwide. In Substudy 1 escalation phase, participants will receive oral ABBV-453 tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral ABBV-453 tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral ABBV-453 tablets. The total study duration is approximately 4.5 years. 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. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG ABBV-453
- DRUG Pomalidomide
Study Locations (20)
Other
- CHU de Liege /ID# 271430 — Liège
- Rambam Health Care Campus- Haifa /ID# 271256 — Haifa
- Hadassah Medical Center-Hebrew University /ID# 271253 — Jerusalem
New South Wales
- Liverpool Hospital /ID# 272002 — Liverpool
- Calvary Mater Newcastle /ID# 272498 — Waratah
Victoria
- St Vincent's Hospital - Melbourne /ID# 271997 — Fitzroy
- Epworth Hospital /ID# 272497 — Richmond
Tel Aviv
- The Chaim Sheba Medical Center /ID# 271251 — Ramat Gan
- Tel Aviv Sourasky Medical Center /ID# 271252 — Tel Aviv
California
- University of Southern California /ID# 272414 — Los Angeles
Michigan
- University of Michigan Health System - Ann Arbor /ID# 271536 — Ann Arbor
New York
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214 — New York
North Carolina
- University of North Carolina at Chapel Hill /ID# 272454 — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-07-23 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06953960
The ClinicalTrials.gov registry entry for NCT06953960 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06953960 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, New South Wales, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06953960 about?
NCT06953960 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)". 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 change in disease activity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in dis...
What is the current status of trial NCT06953960?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2025-07-23. Estimated completion is 2030-12.
What conditions does trial NCT06953960 study?
This clinical trial studies the following conditions: Multiple Myeloma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06953960?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (DRUG), ABBV-453 (DRUG), Pomalidomide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06953960?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06953960 being conducted?
This trial has 20 study locations across California, Michigan, New York, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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