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Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
NCT05561387 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561387
The ClinicalTrials.gov registry entry for NCT05561387 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05561387 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Alaska, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05561387?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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