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NCT03937635 · ClinicalTrials.gov registry record · Phase 3
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma
A Phase 3 study of Smoldering Plasma Cell Myeloma, sponsored by ECOG-ACRIN Cancer Research Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 288
- Enrollment target
- 20
- Study locations
NCT03937635 is a Phase 3 study of Smoldering Plasma Cell Myeloma that is actively recruiting participants, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 288 participants, above the 107-participant average among 9 other Smoldering Plasma Cell Myeloma trials with a reported enrollment target (169% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT03937635, a Phase 3 study of Smoldering Plasma Cell Myeloma, is actively recruiting participants, sponsored by ECOG-ACRIN Cancer Research Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 288 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Dexamethasone
- DRUG Lenalidomide
- BIOLOGICAL Daratumumab
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
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03937635
The ClinicalTrials.gov registry entry for NCT03937635 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 9 other Smoldering Plasma Cell Myeloma trials with a reported enrollment target (169% higher). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Smoldering Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03937635 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03937635 about?
NCT03937635 is a clinical study titled "Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma". This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killi...
What is the current status of trial NCT03937635?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2019-09-16. Estimated completion is 2029-12-31.
What conditions does trial NCT03937635 study?
This clinical trial studies the following conditions: Smoldering Plasma Cell Myeloma.
What interventions are being tested in trial NCT03937635?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03937635?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03937635 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Related
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