Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for Group 3. There is an equal chance to be assigned to either Group 1 or Group 2. Group 3 is no longer open for enrollment.

Official Title

An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

Keywords

Multiple Myeloma Neoplasms, Plasma Cell Dexamethasone acetate Dexamethasone Nivolumab Pomalidomide Thalidomide BB 1101 Antibodies, Monoclonal Elotuzumab

Eligibility

For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Refractory or relapsed and refractory multiple myeloma
  • Measurable disease
  • Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination

Exclusion Criteria:

  • Solitary bone or extramedullary plasmacytoma disease only
  • Active plasma cell leukemia

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • UC San Diego Moores Cancer Ctr
    La Jolla California 92093-0698 United States
  • Scripps Health Dba Scripps Clinical Research Services
    La Jolla California 92037 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT02726581
Phase
Phase 3
Study Type
Interventional
Last Updated
October 8, 2018