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NCT07624513 · ClinicalTrials.gov registry record · Phase 3
Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma
A Phase 3 study, sponsored by Dana-Farber Cancer Institute.
- Not yet
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
NCT07624513: Clinical Trial Phase 3 study, sponsored by Dana-Farber Cancer Institute.
NCT07624513 is a Phase 3 study that has not yet begun recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 720 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07624513, a Phase 3 study, has not yet begun recruiting, sponsored by Dana-Farber Cancer Institute.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the best treatment approach based on the risk profile of the cancer cells and on how the disease responds to treatment. This is a randomized research study evaluating treatment for transplant-eligible participants with newly diagnosed multiple myeloma. Induction therapy in this study includes the drugs isatuximab, iberdomide, bortezomib, and dexamethasone. After induction therapy, participants will receive consolidation and maintenance therapy that is adapted based on their risk profile and response to treatment. The research study procedures include: screening for eligibility, study visits, blood and bone marrow tests, disease assessments, treatment with study drugs, and follow-up visits. It is expected that about 720 participants will take part in this study.
Primary Outcome
sMRD-negative CR rate is defined as the proportion of participants who sustain MRD negativity at a minimum 10\^-5 sensitivity assessed by next-generation sequencing (NGS) during the time of confirmed CR or better response per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC).
Interventions
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Isatuximab
- DRUG Iberdomide
- DRUG Bortezomib (B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2026-06-08 |
| Est. Completion | 2038-03-01 |
| Phase | Phase 3 |
What is known before NCT07624513 opens enrollment
NCT07624513 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT07624513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07624513 about?
NCT07624513 is a clinical study titled "Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma". The purpose of the study is to determine the best treatment approach based on the risk profile of the cancer cells and on how the disease responds to treatment. This is a randomized research study evaluating treatment for transplant-eligible participants with newly diagnosed multiple myeloma. Induct...
What is the current status of trial NCT07624513?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 2026-06-08. Estimated completion is 2038-03-01.
What interventions are being tested in trial NCT07624513?
The interventions under investigation include: Melphalan (DRUG), Dexamethasone (DRUG), Isatuximab (DRUG), Iberdomide (DRUG), Bortezomib (B) (DRUG).
Who is sponsoring clinical trial NCT07624513?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07624513's enrollment target sits among peer trials
720 494th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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