- Active, not recruiting
NCT03224507: Phase 2 - Monoclonal Antibody-Based Sequential Therapy for Deep Remission in MM -MASTER
Updated: Sep 22, 2022
MASTER TRIAL
Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma (MASTER)
Dara-KRd
Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma (MASTER)
Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic malignancy in the U.S. No standard curative therapy has yet been found. A variety of therapeutic measures including high dose melphalan, induction therapy, and continuous therapy have been used but the goal of complete response without relapse has not been achieved. More active treatment regimens and better tools for response assessment are needed.
This trial will assess the safety and efficacy of an induction therapy using the combination of dexamethasone, lenalidomide (revlimid), daratumumab (Darzalex) and carfilzomib (Kyprolis) to treat patients with newly diagnosed multiple myeloma. The therapy with KRdD (Kyprolis, Revlimid, dexamethasone, Darzalex) will be followed by autologous hematopoietic cell transplantation (auto-HCT) and KRdD consolidation. Duration of therapy will be guided by eradication of minimal residual disease (MRD). The hypothesis is that the KRdD therapy particularly in combination with the auto-HCT will be safe and lead to deep remission. Patients who become MRD- will discontinue therapy (no maintenance therapy) and be actively monitored for resurgence of MRD or clinical relapse.
Sponsor
Collaborators
ClinicalTrials.gov Identifier: NCT03224507
Official Title: Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma - MASTER Trial
First Posted : July 21, 2017
Click here for details on ClinicalTrials.gov
Drug: KRdD followed by auto-HCT
Drug: KRdD only
Dexamethasone
Lenalidomide (revlimid)
Daratumumab (Darzalex)
Carfilzomib (Kyprolis)
481 Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd), Autologous Transplantation and MRD Response-Adapted Consolidation and Treatment Cessation. Final Primary Endpoint Analysis of the Master Trial
Program: Oral and Poster Abstracts
Type: Oral
Session: 731. Autologous Transplantation: Clinical and Epidemiological I
Hematology Disease Topics & Pathways:
Clinical Trials, Biological, Clinical Research, Plasma Cell Disorders, Clinically Relevant, Diseases, Therapies, Lymphoid Malignancies, Monoclonal Antibody Therapy
Sunday, December 12, 2021: 12:00 PM
OAB-026 - Humoral immune reconstitution after quadruplet therapy, autologous hematopoietic cell transplant (AHCT) and measurable residual disease adapted treatment cessation in newly diagnosed myeloma (NDMM)
#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California
Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone With Minimal Residual Disease Response-Adapted Therapy in Newly Diagnosed Multiple Myeloma
J Clin Oncol;2022 Sep
International Myeloma Foundation
Dec 13, 2019
Dec 16, 2021
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Alabama: University of Alabama at Birmingham
Oregon: Oregon Health and Science University Portland, Oregon
Tennessee: Vanderbilt Ingram Cancer Center Nashville, Tennessee
Wisconsin: University of Wisconsin, school of medicine and public health Madison, Wisconsin
Locations
United States, Alabama
United States, Oregon
United States, Tennessee
United States, Wisconsin