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NCT03224507: Phase 2 - Monoclonal Antibody-Based Sequential Therapy for Deep Remission in MM -MASTER

Updated: Sep 22

MASTER TRIAL

Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma (MASTER)

Dara-KRd

MASTER DaraKRd

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

University of Alabama at Birmingham


Collaborators

Amgen

Janssen Scientific Affairs, LLC

 

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

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Carfilzomib : National Cancer Institute

Carfilzomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

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


Learn more

 

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

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone With Minimal Residual Disease Response-Adapted Therapy in Newly Diagnosed Multiple Myeloma

J Clin Oncol;2022 Sep

Click here for details

 

International Myeloma Foundation


Dec 13, 2019

Dara-KRd, Autologous Transplantation and MRD Response-Adapted Consolidation and Treatment Cessation - YouTube


Dec 16, 2021

MRD-Based Dara-Krd Consolidation in Patients with Newly Diagnosed Multiple Myeloma: MASTER Trial - YouTube


Learn more:

International Myeloma Foundation - YouTube


Related Post:

MRD-Guided Sequential Therapy For Deep Response in Newly Diagnosed Multiple Myeloma - MASTER-2 Trial - Multiple Myeloma Clinical Trials (themyelomaclinicaltrials.com)

 

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




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