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NCT03984097 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
A Phase 1 study of Multiple Myeloma, sponsored by Takeda.
- Active
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 9
- Study locations
NCT03984097: Active Phase 1 study of Multiple Myeloma, sponsored by Takeda.
NCT03984097 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by Takeda. The registered enrollment target is 50 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03984097, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.
Primary Outcome
RP2D of TAK-079 along with lenalidomide-dexamethasone (LenDex) or TAK-079 along with bortezomib, lenalidomide, and dexamethasone (VRd) will be based on number of participants with dose limiting toxicity (DLT). DLTs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Pomalidomide
- DRUG Bortezomib
- DRUG TAK-079
Study Locations (9)
Alabama
- Alabama Oncology - Birmingham
California
- Pacific Cancer Care - Monterey
Maryland
- American Oncology Partners of Maryland, PA - Bethesda
New York
- Columbia University Medical Center - New York
North Carolina
- Levine Cancer Institute - Charlotte
Ohio
- Good Samaritan Hospital - Cincinnati
Oregon
- Oregon Health & Science University - Portland
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2026-03-25 |
| Phase | Phase 1 |
What the registry record for NCT03984097 still lists
NCT03984097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03984097 lists 9 locations in 9 states (Alabama, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT03984097 about?
NCT03984097 is a clinical study titled "A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)". The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previous...
What is the current status of trial NCT03984097?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2019-07-29. Estimated completion is 2026-03-25.
What conditions does trial NCT03984097 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03984097?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Pomalidomide (DRUG), Bortezomib (DRUG), TAK-079 (DRUG).
Who is sponsoring clinical trial NCT03984097?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03984097 being conducted?
This trial has 9 study locations across Alabama, California, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03984097's enrollment target sits among peer trials
50 252nd of 438 higher than 173 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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