- Active, not recruiting
NCT02252172 : Phase 3 - Dara, Lena & Dex VS Len & Dex in previously untreated Myeloma - MAIA STUDY
Updated: Oct 20, 2022
The MAIA Study
NCT02252172: Phase 3: Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
Sponsor
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT02252172
Official Title: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
First Posted: September 30, 2014
Click here to see details on Clinicaltrials.gov
Drug: Daratumumab IV (Darzalex)
Drug: Lenalidomide (Revlimid)
Drug: Dexamethasone (Decadron)
Drug: Daratumumab SC (Darzalex Faspro)
Patient Information - FDA Approved Drugs Multiple Myeloma
Late-Breaking Abstracts Session| ASH 2018 I November 29, 2018
Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA)
653.Myeloma: Therapy, excluding Transplantation| November 13, 2019
Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant: Updated Analysis of Maia
MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma.
N Engl J Med. 2019 May
2276 Updated Analysis of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): The Phase 3 Maia Study
Program: Oral and Poster Abstracts
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster II
Hematology Disease Topics & Pathways:
multiple myeloma, Biological, Adult, antibodies, Diseases, Therapies, Plasma Cell Disorders, Study Population, Lymphoid Malignancies
Sunday, December 6, 2020, 7:00 AM-3:30 PM
2317 Sustained Minimal Residual Disease (MRD) Negativity and Clinical Efficacy in Transplant-Ineligible (TIE) Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Treated with Daratumumab-Based Regimens: Analysis of Maia and Alcyone
Program: Oral and Poster Abstracts
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster II
Sunday, December 6, 2020, 7:00 AM-3:30 PM
Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial.
Lancet Oncol. 2021 Nov
Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, MAIA.
Blood. 2021 Jul
Sustained Minimal Residual Disease Negativity With Daratumumab in Newly Diagnosed Multiple Myeloma: MAIA and ALCYONE.
Blood. 2021 Jul
Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial.
J Clin Oncol. 2021 Jan
OVERALL SURVIVAL RESULTS WITH DARATUMUMAB, LENALIDOMIDE, AND DEXAMETHASONE VERSUS LENALIDOMIDE AND DEXAMETHASONE IN TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA: PHASE 3 MAIA STUDY
EHA 2021 Congress - The European Hematology Association ; EHA 2021 Virtual ,June 12, 2021
Click here to see details on EHA website.
OAB-039 - Treatment duration and long-term outcomes with daratumumab in transplant-ineligible newly diagnosed multiple myeloma from the phase 3 MAIA study
#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California
- Multiple locations
- International study
- Minnesota: Mayo Clinic Rochester Minnesota
- Texas: The University of Texas MD Anderson Cancer Center Houston
- Massachusetts: Massachusetts General Hospital Boston
- North Carolina: Levine Cancer Institute Charlotte
- Illinois: University of Chicago
Locations
United States, Alabama
United States, Arizona
United States, California
United States, Colorado
United States, Connecticut
United States, District of Columbia
United States, Florida
United States, Georgia
United States, Illinois
United States, Indiana
United States, Iowa
United States, Kentucky
United States, Louisiana
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, Missouri
United States, Nebraska
United States, New Hampshire
United States, New Jersey
United States, New York
United States, North Carolina
United States, Ohio
United States, Oregon
United States, Pennsylvania
United States, South Carolina
United States, South Dakota
United States, Tennessee
United States, Texas
United States, Utah
United States, Washington
Canada, Alberta
Canada, Ontario
Canada, Quebec
Canada
Europe
United Kingdom
Australia
Austria
Belgium
Denmark
France
Germany
Ireland
Israel
Netherlands
Sweden
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