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NCT04071457 · ClinicalTrials.gov registry record · Phase 3
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
A Phase 3 study of Multiple Myeloma, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 1,100
- Enrollment target
- 20
- Study locations
NCT04071457 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 1,100 participants, above the 544-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (102% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT04071457, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,100 participants
- Enrollment target
- 20
- Study locations
Study Summary
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG Daratumumab/rHuPH20
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
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- 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
- CARTI Cancer Center - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
California
- Kaiser Permanente-Anaheim - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2040-07-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04071457
The ClinicalTrials.gov registry entry for NCT04071457 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 544-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (102% higher). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT04071457 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04071457 about?
NCT04071457 is a clinical study titled "S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration". Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHu...
What is the current status of trial NCT04071457?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2019-08-13. Estimated completion is 2040-07-01.
What conditions does trial NCT04071457 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04071457?
The interventions under investigation include: Lenalidomide (DRUG), Daratumumab/rHuPH20 (DRUG).
Who is sponsoring clinical trial NCT04071457?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04071457 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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