- Recruiting
NCT04071457: Phase 3: S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maint. NDMM DRAMMATIC
Updated: Sep 7, 2022
DRAMMATIC
SWOG S1803
NCT04071457: Phase 3: S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration (DRAMMATIC)
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.
Sponsor
Collaborators
National Cancer Institute (NCI)
Janssen, LP
Adaptive
Multiple Locations
ClinicalTrials.gov Identifier: NCT04052880
Official Title: S1803, Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients With Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
First Posted : August 28, 2019
Click here for details on ClinicalTrials.gov
Drug: Lenalidomide
Drug: Daratumumab/rHuPH20
1515 Phase III Study of Daratumumab/rhuph20 (nsc- 810307) + Lenalidomide or Lenalidomide As Post-Autologous Stem Cell Transplant Maintenance Therapyin Patients with Multiple Myeloma (mm) Using Minimal Residual Disease Todirect Therapy Duration (DRAMMATIC study): SWOG s1803
Program: Oral and Poster Abstracts
Session: 731. Clinical Autologous Transplantation: Results: Poster I
Hematology Disease Topics & Pathways:
Adult, Non-Biological, Therapies, Study Population, Clinically relevant
Saturday, December 5, 2020, 7:00 AM-3:30 PM
Locations
United States, Alaska
United States, Arizona
United States, Arkansas
United States, California
United States, Colorado
United States, Delaware
United States, Florida
United States, Georgia
United States, Hawaii
United States, Idaho
United States, Illinois
United States, Indiana
United States, Iowa
United States, Kansas
United States, Kentucky
United States, Louisiana
United States, Maine
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, Mississippi
United States, Missouri
United States, Montana
United States, Nebraska
United States, New Jersey
United States, New Mexico
United States, New York
United States, North Carolina
United States, North Dakota
United States, Ohio
United States, Oklahoma
United States, Oregon
United States, Pennsylvania
United States, South Carolina
United States, South Dakota
United States, Texas
United States, Utah
United States, Virginia
United States, Washington
United States, West Virginia
United States, Wisconsin
United States, Wyoming