• Active, not recruiting

NCT03012880: Phase 2 - Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab NDMM

Updated: Apr 24


DARA-IRD

NCT03012880: Phase 2 - Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma


This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab may work better in treating patients with newly diagnosed multiple myeloma.


Sponsor:

Mayo Clinic

Collaborator:

National Cancer Institute (NCI)


ClinicalTrials.gov Identifier: NCT03012880


Official Title: Phase 2 Trial of Ixazomib, Lenalidomide, Dexamethasone, and Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

https://www.clinicaltrials.gov/ct2/show/NCT03012880

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

 

Drug: Lenalidomide

Biological: Daratumumab

Drug: Dexamethasone

Drug: Ixazomib Citrate

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

 

3196 Daratumumab, Ixazomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Program: Oral and Poster Abstracts

Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster III

Hematology Disease Topics & Pathways:

Therapies, Combinations, Clinically relevant

Monday, December 7, 2020, 7:00 AM-3:30 PM


Conclusion: Dara-IRd is an active regimen in newly diagnosed MM, with high overall rates of response and deep responses that improved over time with therapy. Early discontinuation of dexamethasone does not appear to impact the depth, rate or kinetics of response. The toxicities were manageable, with dose modifications. All patients were able to collect stem cells when required, though majority needed plerixafor.

https://ash.confex.com/ash/2020/webprogram/Paper139372.html



653.Myeloma: Therapy, excluding Transplantation| November 13, 2019

Phase 2 Trial of Daratumumab, Ixazomib, Lenalidomide and Modified Dose Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Conclusion: Our early results suggest that the combination of daratumumab, ixazomib, lenalidomide and modified dose dexamethasone is well-tolerated, with excellent activity, and does not adversely impact stem-cell mobilization in patients with NDMM.

https://ashpublications.org/blood/article/134/Supplement_1/864/427138/Phase-2-Trial-of-Daratumumab-Ixazomib-Lenalidomide







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