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S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
NCT04071457 · View on ClinicalTrials.gov ↗
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 |
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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. 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 1,100 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 Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions — of which Lenalidomide 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: NCT04071457 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Alaska, Arizona, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04071457?
The interventions under investigation include: Lenalidomide (DRUG), Daratumumab/rHuPH20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04071457?
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 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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