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NCT05561387 · ClinicalTrials.gov registry record · Phase 3
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
A Phase 3 study of Plasma Cell Myeloma, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT05561387: Recruiting Phase 3 study of Plasma Cell Myeloma, sponsored by SWOG Cancer Research Network.
NCT05561387 is a Phase 3 study of Plasma Cell Myeloma that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 510 participants, above the 192-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (166% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05561387, a Phase 3 study of Plasma Cell Myeloma, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
Primary Outcome
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by fluorescence in situ hybridization (iFISH) (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Bortezomib
- DRUG Daratumumab and Hyaluronidase-fihj
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Marshall Cancer Center - Cameron Park
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- Fremont - Rideout Cancer Center - Marysville
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2023-10-12 |
| Est. Completion | 2031-05-30 |
| Phase | Phase 3 |
What NCT05561387 shows while recruiting
NCT05561387 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (166% higher).
The record links to 1 condition, with Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05561387 names 20 study sites across 4 states, led by Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05561387 about?
NCT05561387 is a clinical study titled "Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment". This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, a...
What is the current status of trial NCT05561387?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2023-10-12. Estimated completion is 2031-05-30.
What conditions does trial NCT05561387 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma.
What interventions are being tested in trial NCT05561387?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG), Daratumumab and Hyaluronidase-fihj (DRUG).
Who is sponsoring clinical trial NCT05561387?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561387 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Plasma Cell 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 NCT05561387's enrollment target sits among peer trials
510 4th of 32 higher than 29 of 32 other Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plasma Cell 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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