top of page
  • Active, not recruiting

NCT01850524: Phase 3 - TOURMALINE-MM2 - Oral Ixazomib + Lenalidomide/Dex Vs Placebo + Len/Dex NDMM

Updated: Oct 4, 2022

TOURMALINE-MM2

TOURMALINE-MM2

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma


The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.


Sponsor

Millennium Pharmaceuticals, Inc.

 

ClinicalTrials.gov Identifier: NCT01850524

Official Title: 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

First Posted : May 9, 2013

Click here for details on clinicalTrials.gov

 

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

Drug: Ixazomib

Drug: Placebo

Drug: Dexamethasone

Drug: Lenalidomide

 

Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma

Blood; 2021

https://pubmed.ncbi.nlm.nih.gov/33763699/

 

- Multiple locations

- International study


- Alabama: University of Alabama at Birmingham

- Arkansas: University of Arkansas Little Rock

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Minnesota: Mayo Clinic Rochester Minnesota

- Georgia: Emory University Atlanta

 

RELATED POSTS

MCT: MYELOMA CLINICAL TRIALS WITH IXAZOMIB


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

Click here for details


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

Click here for details


NCT01564537: TOURMALINE-MM1 - Phase 3 - Comparing Oral Ixazomib + Lenalidomide/Dex Vs Placebo + Len/Dex RRMM

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

Click here for details


NCT03941860: EAA171 - OPTIMUM - Phase 3 - Addition of Ixazomib to Lenalidomide in Patients With Residual Myeloma

Optimizing Prolonged Treatment in Myeloma Using MRD Assessment (OPTIMUM)

Click here for details


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)

Click here for details


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)

Click here for details


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

Click here for details


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

Click here for details


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

Click here for details


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

Click here for details





Posts Archive
bottom of page