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Spots Global Cancer Trial Database for Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma

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Trial Identification

Brief Title: Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma

Official Title: Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma - MASTER Trial

Study ID: NCT03224507

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

Oregon Health and Science University, Portland, Oregon, United States

Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States

University of Wisconsin, school of medicine and public health, Madison, Wisconsin, United States

Contact Details

Name: Luciano J Costa, MD, PhD

Affiliation: University of Alabama at Birmingham

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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