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NCT05259839 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 283
- Enrollment target
- 20
- Study locations
NCT05259839: Active Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie.
NCT05259839 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 283 participants, above the 152-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05259839, 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
- 283 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 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.
Primary Outcome
DLT events as described in the protocol will be assessed.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Pomalidomide
- DRUG Etentamig
Study Locations (20)
Victoria
- Monash Health - Monash Medical Centre /ID# 244403 - Clayton
- St Vincent's Hospital Melbourne /ID# 256879 - Fitzroy Melbourne
- Peter MacCallum Cancer Ctr /ID# 256880 - Melbourne
Florida
- Sylvester Comprehensive Cancer Center /ID# 243673 - Miami
- Moffitt Cancer Center /ID# 243437 - Tampa
Massachusetts
- Dana-Farber Cancer Institute /ID# 249529 - Boston
- University of Massachusetts - Worcester /ID# 243977 - Worcester
New York
- Rutenberg Cancer Center /ID# 244647 - New York
- Memorial Sloan Kettering Cancer Center /ID# 244656 - New York
New South Wales
- St George Hospital /ID# 243740 - Kogarah
- Calvary Mater Newcastle /ID# 243730 - Waratah
Arkansas
- University of Arkansas for Medical Sciences /ID# 243096 - Little Rock
Maryland
- University of Maryland, Baltimore /ID# 243679 - Baltimore
Michigan
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2022-10-20 |
| Est. Completion | 2033-09 |
| Phase | Phase 1 |
What the registry record for NCT05259839 still lists
NCT05259839 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, above the 152-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (86% higher).
The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT05259839 names 20 study sites across 14 states, led by Victoria, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05259839 about?
NCT05259839 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05259839?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 283 participants. The study started on 2022-10-20. Estimated completion is 2033-09.
What conditions does trial NCT05259839 study?
This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.
What interventions are being tested in trial NCT05259839?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Etentamig (DRUG).
Who is sponsoring clinical trial NCT05259839?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05259839 being conducted?
This trial has 20 study locations across Arkansas, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05259839's enrollment target sits among peer trials
283 3rd of 14 higher than 12 of 14 other Relapsed/Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsed/Refractory Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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