Trial intelligence / Profile preview

RVD Lite in Newly Diagnosed Multiple Myeloma

NCT01782963Phase 2

Key facts

Status
Completed
Start
Mar 2013
Primary completion
Dec 2016
Countries
1
Sponsor
Massachusetts General Hospital
Modality
Modified Peptides, Orthosteric Ligands
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, open-label, single-arm trial of lenalidomide, bortezomib and dexamethasone in multiple myeloma (MM), sponsored by Massachusetts General Hospital. Primary endpoint: Objective Response Rate at 2 years. Started Mar 2013; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Treatment Arm

    RVD Lite Regimen

03

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Number of Participants With Grade 3 or Higher Treatment Related Adverse Events

  • Median Progression Free Survival

  • Median Overall Survival

  • Median Time to Response

  • Response Rate With Respect to Cytogenetic Characteristics

  • Mean Plasma Bortezomib Concentration

  • Pharmacogenomic Markers of Neuropathy

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