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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: Active Phase 3 study of Multiple Myeloma, sponsored by SWOG Cancer Research Network.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Overall survival will evaluated using a weighted log-rank test and will be compared between primary treatment arms. All eligible patients with valid consent will be included in the analysis. Patients last known to be alive are censored at the date of last contact.

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

FieldValue
Enrollment Target 1,100 participants
Start Date 2019-08-13
Est. Completion 2040-07-01
Phase Phase 3
SWOG Cancer Research Network

270 total trials

What the registry record for NCT04071457 still lists

NCT04071457 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 544-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (102% higher).

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 names 20 study sites across 4 states, led by 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.

Similar trials for Multiple 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 NCT04071457's enrollment target sits among peer trials

1,100 20th of 438 higher than 419 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple 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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Source: ClinicalTrials.gov NCT04071457, the US trial registry maintained by the National Library of Medicine. NCT04071457 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.