• Active, not recruiting

NCT02252172 : Phase 3 - Dara, Lena & Dex VS Len & Dex in previously untreated Myeloma - MAIA STUDY

Updated: Oct 20

The MAIA Study

NCT02252172: Phase 3: Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

MAIA STUDY

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

Janssen Research & Development, LLC


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

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

Drug: Daratumumab IV (Darzalex)

Drug: Lenalidomide (Revlimid)

Drug: Dexamethasone (Decadron)

Drug: Daratumumab SC (Darzalex Faspro)

 

Patient Information - FDA Approved Drugs Multiple Myeloma

Drugs | Myeloma Clinical Trials (themyelomaclinicaltrials.com)

 

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)

https://doi.org/10.1182/blood-2018-120737

 

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

https://doi.org/10.1182/blood-2019-123426

 

MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma.

N Engl J Med. 2019 May

https://pubmed.ncbi.nlm.nih.gov/31141632/

 

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

https://ash.confex.com/ash/2020/webprogram/Paper134847.html

 

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

https://ash.confex.com/ash/2020/webprogram/Paper134928.html

 

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

https://pubmed.ncbi.nlm.nih.gov/34655533/

 

Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, MAIA.

Blood. 2021 Jul

https://pubmed.ncbi.nlm.nih.gov/34289038/

 

Sustained Minimal Residual Disease Negativity With Daratumumab in Newly Diagnosed Multiple Myeloma: MAIA and ALCYONE.

Blood. 2021 Jul

https://pubmed.ncbi.nlm.nih.gov/34269818/

 

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

https://pubmed.ncbi.nlm.nih.gov/33326255/

 

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

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


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

 

- 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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