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

Updated: Sep 7, 2022


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.


Southwest Oncology Group


National Cancer Institute (NCI)

Janssen, LP


Multiple Locations 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

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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

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