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E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

NCT02279394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-06-09

Study results available
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Summary

This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy.

Conditions

  • Smoldering Myeloma
  • Smoldering Multiple Myeloma

Interventions

DRUG

Elotuzumab

10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8

DRUG

Lenalidomide

25 mg Oral; Days 1-21 days Cycles 1-24

DRUG

Dexamethasone

40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • Blood Cancer Research Partnership

    collaborator OTHER

  • Multiple Myeloma Research Consortium

    collaborator NETWORK

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Irene Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-11
Primary Completion
2018-12-12
Completion
2022-01-26

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279394 on ClinicalTrials.gov