• Recruiting

NCT04071457: Phase 3: S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maint. NDMM DRAMMATIC

Updated: Sep 7

DRAMMATIC

SWOG S1803

DRAMMATIC

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

Southwest Oncology Group


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

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


MRD Testing

 

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


Click here for details

 

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


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