NCT01782963: Phase 2 - Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) (RVD Lite)

RVD Lite

NDMM

NCT01782963: Phase 2 - Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) (RVD Lite)

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.

Sponsor:

Massachusetts General Hospital

ClinicalTrials.gov Identifier: NCT01782963

Official Title: A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma

https://clinicaltrials.gov/ct2/show/NCT01782963

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Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

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A phase 2 study of modified lenalidomide, bortezomib and dexamethasone in transplant-ineligible multiple myeloma

Br J Haematol; 2018

https://pubmed.ncbi.nlm.nih.gov/29740809/

4217 A Phase II Study of Modified Lenalidomide, Bortezomib, and Dexamethasone (RVD-lite) for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma

Myeloma: Therapy, excluding Transplantation

Program: Oral and Poster Abstracts

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

Monday, December 7, 2015, 6:00 PM-8:00 PM

Hall A, Level 2 (Orange County Convention Center)

Conclusions: Modified RVD is a well-tolerated and highly effective regimen in the transplant-ineligible population. The ORR rate after 4 cycles suggests that this combination at modified doses and on a weekly schedule is very active. The side effect profile proved manageable and was well tolerated in an older population despite the variance of performance status at study entry. There were no significant differences in plasma concentrations of bortezomib observed between IV and SC dosing. The study is fully accrued and this analysis suggests that alternative dosing and schedule of RVD may both improve tolerability and enhance clinical benefit in newly diagnosed, transplant-ineligible MM pts.

https://ash.confex.com/ash/2015/webprogramscheduler/Paper80503.html

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- Massachusetts: Massachusetts General Hospital Boston

Drug: Lenalidomide

Drug: Bortezomib

Drug: Dexamethasone