• Active, not recruiting

NCT03617731: Phase 3 - Effect of Isatuximab to RVd Induction and Len Maintenance in NDMM (GMMG HD7)

Updated: Sep 15


NCT03617731: Phase 3 - Effect of Isatuximab to RVd Induction and Lenalidomide Maintenance in NDMM (GMMG HD7)


German-speaking myeloma multicenter group

(GMMG)

GMMG-HD7 myeloma trial german group

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


HD7 Study – GMMG Study Group


GMMG - The German Speaking Myeloma Multicenter Group

 

Isatuximab

Lenaliodomide (R)

Bortezomib (V)

Dexamethasone (d)

 

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


Learn more


 

Location

Europe

Germany







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