A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Nivolumab	Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	95 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Actual Study Start Date :	December 18, 2015
Estimated Primary Completion Date :	October 27, 2019
Estimated Study Completion Date :	January 15, 2020

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd); patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.	Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Drug: Nivolumab
Experimental: Elotuzumab + Nivolumab (EN); Patients will receive treatment with a combination of elotuzumab and nivolumab	Drug: Elotuzumab Drug: Nivolumab

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. EPd cohort: Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]
   PFS is defined as the time from first dosing date to the date of the first documented progression per IMWG uniform criteria or death due to any cause, whichever occurs first
2. EN Cohort: Objective Response Rate (ORR) [ Time Frame: Approximately 5 years ]
   ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better

Secondary Outcome Measures :

1. EPd Cohort: Objective Response Rate (ORR) [ Time Frame: Approximately 5 years ]
   ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better
2. EPd Cohort: Overall Survival Rate (OS) [ Time Frame: Approximately 5 years ]
   OS is defined as the time from first dosing date to the date of death from any cause. A subject who has not died will be censored at last known date alive
3. EN Cohort: Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Inclusion Criteria:

1. All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
2. ECOG Performance Status less than or equal to 2
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.

4. EPd Cohort:

   • must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
   • Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.

5. EN Cohort:

   • Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.

Exclusion Criteria:

1. Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
2. Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
3. Subjects with Central Nervous System involvement with multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 24 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol Myers Squibb	Bristol-Myers Squibb

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trial Information 

FDA Safety Alerts and Recalls 

BMS Clinical Trial Patient Recruiting 

Investigator Inquiry Form 

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT02612779 History of Changes
Other Study ID Numbers:	CA204-142
First Posted:	November 24, 2015
Last Update Posted:	February 1, 2018
Last Verified:	January 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone acetate	Dexamethasone; Lenalidomide; Nivolumab; Pomalidomide; Thalidomide; BB 1101; Antibodies, Monoclonal; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones