• Recruiting

NCT03720041: Phase 3 Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Elig. New MM (FiTNEss)

Updated: Oct 4

Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma (FiTNEss)

Myeloma XIV Trial

FiTNEss (UK-MRA Myeloma XIV) - Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma


A phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant.


All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose-modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation.


Sponsor:

University of Leeds


Collaborators:

Cancer Research UK

Takeda

Celgene


Multiple Locations

UK study

 

ClinicalTrials.gov Identifier: NCT03720041

Official Title: 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)

First Posted : October 25, 2018

Click here for details on ClinicalTrials.gov

 

Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm

Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm

Drug: R2: Lenalidomide plus placebo maintenance

Drug: R2: Lenalidomide + ixazomib maintenance

 

81 Fitness, a UK Myeloma Research Alliance (UK-MRA) Frailty-Adjusted Therapy Study, Supports the Feasibility of Recruiting Frail Newly Diagnosed Myeloma Patients to Large Clinical Trials

Program: Oral and Poster Abstracts

Type: Oral

Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Phase 2 and 3 Trials in Myeloma

Hematology Disease Topics & Pathways:

Clinical Trials, Age Inequities, Clinical Research, Plasma Cell Disorders, Clinically Relevant, Diseases, Therapies, Lymphoid Malignancies, Diversity, Equity, and Inclusion (DEI), Clinical Practice (e.g. Guidelines, Health Outcomes and Services, and Survivorship, Value; etc.)

Saturday, December 11, 2021: 10:00 AM


Learn more

 

Locations

United Kingdom

University of Leeds

Principal Investigator: Gordon Cook, MD University of Leeds

Principal Investigator: Graham Jackson, MD Freeman Hospital, Newcastle-Upon-Tyne

 

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


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

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


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