NCT03617731: Phase 3 - Effect of Isatuximab to RVd Induction and Len Maintenance in NDMM (GMMG HD7)
Updated: Sep 15, 2022
NCT03617731: Phase 3 - Effect of Isatuximab to RVd Induction and Lenalidomide Maintenance in NDMM (GMMG HD7)
German-speaking myeloma multicenter group
(GMMG)
Trial on the Effect of Isatuximab to Lenaliodomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) and in lenalidomide maintenance treatment
Primary endpoint of the trial was MRD negativity assessed by next-generation flow (NGF, cut off 1x10-5) after induction. Secondary endpoints included rates of complete response (CR) after induction and safety.
Sponsor
University of Heidelberg Medical Center
Information provided by (Responsible Party) Prof. Dr. Hartmut Goldschmidt, University of Heidelberg Medical Center
German Study
ClinicalTrials.gov Identifier: NCT03617731
Official Title: A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
First Posted : August 6, 2018
Click here for details on ClinicalTrials.gov
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone
Drug: Isatuximab
463 Addition of Isatuximab to Lenalidomide, Bortezomib and Dexamethasone As Induction Therapy for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma Patients: The Phase III GMMG-HD7 Trial
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials; treatment of NDMM and amyloidosis patients
Hematology Disease Topics & Pathways:
Clinical Trials, Clinical Research, Plasma Cell Disorders, Diseases, Lymphoid Malignancies
Sunday, December 12, 2021: 12:00 PM
Location
Europe
Germany