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NCT03732703 · ClinicalTrials.gov registry record · Phase 1
Myeloma-Developing Regimens Using Genomics (MyDRUG)
A Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by Multiple Myeloma Research Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
- 16
- Study locations
NCT03732703: Completed Phase 1 study of Relapsed/Refractory Multiple Myeloma, sponsored by Multiple Myeloma Research Consortium.
NCT03732703 is a Phase 1 study of Relapsed/Refractory Multiple Myeloma that has completed, run by Multiple Myeloma Research Consortium. The registered enrollment target is 103 participants, below the 165-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (38% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03732703, a Phase 1 study of Relapsed/Refractory Multiple Myeloma, has completed, sponsored by Multiple Myeloma Research Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
- 16
- Study locations
Study Summary
The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 25% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 25% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
Primary Outcome
• To evaluate the overall response rate (ORR) with targeted agents used in combination with backbone regimen ixazomib, pomalidomide and dexamethasone (IPd) in patients with an actionable genetic alteration per the International Myeloma Working Group \[IMWG\] consensus criteria (Kumar et al, 2016)
Conditions Studied
Interventions
- DRUG Abemaciclib, dexamethasone, ixazomib, pomalidomide
- DRUG Enasidenib, dexamethasone, ixazomib, pomalidomide
- DRUG Cobimetinib, dexamethasone, ixazomib, pomalidomide
- DRUG Erdafitinib, dexamethasone, ixazomib, pomalidomide
- DRUG Venetoclax, dexamethasone, ixazomib, pomalidomide
Study Locations (16)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Beth Israel Deaconess - Boston
- Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan Health System - Ann Arbor
- Karmanos Cancer Center - Detroit
New York
- Mount Sinai School of Medicine - New York
- Memorial Sloan Kettering Cancer Center - New York
Arizona
- Mayo Clinic - Arizona - Phoenix
California
- City of Hope - Duarte
Georgia
- Emory University - Atlanta
Minnesota
- Mayo Clinic - Minnesota - Rochester
Missouri
- Washington University School of Medicine Division of Medical Oncology - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT03732703 record still lists
NCT03732703 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 165-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Abemaciclib, dexamethasone, ixazomib, pomalidomide is the first listed.
NCT03732703 lists 16 locations in 12 states (Massachusetts, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT03732703 about?
NCT03732703 is a clinical study titled "Myeloma-Developing Regimens Using Genomics (MyDRUG)". The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 25% mutation to any of the following genes; ...
What is the current status of trial NCT03732703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2019-04-01. Estimated completion is 2024-12-31.
What conditions does trial NCT03732703 study?
This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.
What interventions are being tested in trial NCT03732703?
The interventions under investigation include: Abemaciclib, dexamethasone, ixazomib, pomalidomide (DRUG), Enasidenib, dexamethasone, ixazomib, pomalidomide (DRUG), Cobimetinib, dexamethasone, ixazomib, pomalidomide (DRUG), Erdafitinib, dexamethasone, ixazomib, pomalidomide (DRUG), Venetoclax, dexamethasone, ixazomib, pomalidomide (DRUG).
Who is sponsoring clinical trial NCT03732703?
This trial is sponsored by Multiple Myeloma Research Consortium, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03732703 being conducted?
This trial has 16 study locations across Arizona, California, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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