NCT01564537: Phase 3 - TOURMALINE-MM1 - Oral Ixazomib + Len/Dex Vs Placebo + Len/Dex RRMM
- Active, not recruiting
- Dec 24, 2016
- 3 min read
Updated: Oct 4, 2022
TOURMALINE-MM1
A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).
Sponsor
Information provided by (Responsible Party)
Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01564537
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
First Posted : March 28, 2012
Click here for details on ClinicalTrials.gov
N Engl J Med. 2016
Blood. 2017 Dec
Haematologica. 2017 Oct
J Hematol Oncol. 2017
Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Placebo
- Arkansas: University of Arkansas Little Rock
- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston
- Minnesota: Mayo Clinic Rochester Minnesota
- New Jersey: Hackensack University Medical Center
- New York: Columbia University Medical Center New York
- New York: Roswell Park Cancer Institute Buffalo
- Wisconsin: Medical College Of Wisconsin Milwaukee
- Washington: Fred Hutchinson Cancer Center Seattle
Locations
United States, Arkansas
United States, California
United States, Florida
United States, Georgia
United States, Illinois
United States, Massachusetts
United States, Minnesota
United States, New Jersey
United States, New York
United States, North Carolina
United States, Pennsylvania
United States, South Carolina
United States, Washington
United States, West Virginia
United States, Wisconsin
Canada, Alberta
Canada, British Columbia
Canada, New Brunswick
Canada, Quebec
RELATED POSTS
NCT02312258: TOURMALINE-MM4 - Phase 3: A Study of Oral Ixazomib Maintenance Therapy in Participants With NDMM-TIE
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
NCT02181413: TOURMALINE-MM3 - Phase 3 - Oral Ixazomib Citrate (MLN9708) Maintenance in NDMM Post ASCT
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
NCT01850524: TOURMALINE-MM2 - Phase 3 - Comparing Oral Ixazomib + Lenalidomide/Dex Vs Placebo + Len/Dex NDMM
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
NCT03941860: EAA171 - OPTIMUM - Phase 3 - Addition of Ixazomib to Lenalidomide in Patients With Residual Myeloma
Optimizing Prolonged Treatment in Myeloma Using MRD Assessment (OPTIMUM)
NCT03720041: Myeloma XIV - (FiTNEss) - Phase 3: Frailty-adjusted Therapy in Transplant Non-Elig. NDMM
Myeloma XIV: A Phase III Trial to Compare Standard and Frailty-adjusted Induction Therapy With Ixazomib, Lenalidomide and Dexamethasone (IRD) and Maintenance Lenalidomide (R) to Lenalidomide Plus Ixazomib (R+I)
NCT03651128: (KarMMa-3) - Phase 3 - Study of bb2121 Vs Standard Regimens Refractory Myeloma RRMM
A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)
NCT03562169: Myeloma XII (ACCoRd) - Phase 3: Ixazomib in Autologous Stem Cell Transplant in RRMM
A Phase III Study to Determine the Role of Ixazomib as an Augmented Conditioning Therapy in Salvage Autologous Stem Cell Transplant (ASCT) and as a Post-ASCT Consolidation and Maintenance Strategy in Patients With Relapsed Multiple Myeloma
NCT02406144: GEM2014MAIN - Phase 3 - Maintenance Lenalidomide, Dex VS Lenalidomide, Dex. & MLN9708 After ASCT NDMM
Trial Studying Maintenance Treatment With Lenalidomide and Dexamethasone Versus Lenalidomide, Dexamethasone and MLN9708 After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly-diagnosed Symptomatic Multiple Myeloma
NCT02119468: Phase 1/2: Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With RRMM
Phase I/II Trial of MLN9708 Plus Pomalidomide and Dexamethasone for Relapsed or Relapsed Refractory Multiple Myeloma
NCT01415882: Phase 2: Ixazomib Citrate in Relapsed Multiple Myeloma, Not Refractory to Bortezomib RRMM
Phase 2 Trial of Ixazomib Combinations in Patients With Relapsed Multiple Myeloma