An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

Multiple Myeloma Clinical Trial

Official title:

An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654132
• Other study ID #: CA204-125
• Secondary ID: 2014-003282-19
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2016
• Est. completion date: October 21, 2021

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 21, 2021
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• = 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination

• Documented refractory or relapsed and refractory multiple myeloma

• Refractory to proteosome inhibitor and lenalidomide, and to last treatment

• Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment

• Measurable disease at screening

• Eastern Cooperative Oncology Group (ECOG) performance status = 2

Exclusion Criteria:

• Active plasma cell leukemia

• Prior treatment with pomalidomide

• Unable to tolerate thromboembolic prophylaxis while on the study

• Prior autologous stem cell transplant within 12 weeks

• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elotuzumab

• Pomalidomide

• Dexamethasone

Locations

Country	Name	City	State
Australia	Local Institution	South Brisbane	Queensland
Canada	CISSS de l'Outaouais	Gatineau	Quebec
Canada	Local Institution	London	Ontario
Canada	Local Institution - 0048	Montreal	Quebec
France	Local Institution - 0022	Nantes Cedex 1
France	Local Institution - 0021	Paris Cedex 12
France	Local Institution - 0020	Pessac
France	Local Institution - 0019	Poitiers Cedex
France	Local Institution	Saint Pierre Cedex
Germany	Universitaetsklinikum Carl Gustav Carus	Dresden
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	St. Barbara-Klinik	Hamm
Germany	Local Institution - 0041	Heidelberg
Germany	Local Institution - 0056	Kiel
Germany	Klinikum Der Johannes Gutenberg Universitaet Mainz	Mainz
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Greece	Alexandra General Hospital Of Athens	Athens
Greece	Laiko University Hospital	Athens
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona	Ancona
Italy	A. O. U. Di Bologna, Policlinico S. Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Local Institution	Roma
Italy	Universita' La Sapienza	Roma
Italy	Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino	Torino
Japan	Local Institution - 0067	Kasama-shi
Japan	Local Institution - 0031	Kyoto-shi	Kyoto
Japan	Local Institution - 0069	Morioka-shi	Iwate
Japan	Local Institution - 0030	Nagoya-shi	Aichi
Japan	Local Institution - 0029	Niigata-shi	Niigata
Japan	Local Institution - 0032	Okayama
Japan	Local Institution - 0027	Shibuya-ku	Tokyo
Japan	Local Institution - 0028	Tachikawa-shi	Tokyo
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Maastrict
Netherlands	Local Institution	Utrecht
Poland	Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych	Chorzow
Poland	Local Institution	Lublin
Poland	Oddzial Hematologii i Transplantacji Szpiku	Poznan
Spain	Local Institution	Barcelona
Spain	Local Institution - 0024	Madrid
Spain	Local Institution	Pamplona	Navarra
Spain	Local Institution	Valencia
United States	Winship Cancer Institute	Atlanta	Georgia
United States	Beth Israel Comprehensive Cancer Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute.	Boston	Massachusetts
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	St Francis Hospital	Greenville	South Carolina
United States	Investigative Clinical Research Of Indiana, Llc	Indianapolis	Indiana
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	Northern Utah Associates	Ogden	Utah
United States	Va Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Rochester General Hospital	Rochester	New York
United States	University Of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	AbbVie, Celgene

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Greece,  Italy,  Japan,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder	From randomization to date of progression or death (up to approximately 21 months)
Secondary	Objective Response Rate (ORR)	ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment; CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour; PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.	From first dose to disease progression (up to approximately 21 months)
Secondary	Overall Survival (OS)	OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.	From randomization to death (up to approximately 52 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting