Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

• Status: Completed
• Trial end date: 2018-07-11
• Target enrollment: 0
• Participant gender: All

Summary

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab; Lenalidomide; Thalidomide

Criteria

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

Inclusion Criteria:

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

• Documented evidence of active multiple myeloma:

• Newly diagnosed, not candidate for transplant

• Relapsed/refractory who have received up to 3 prior lines of therapy

• Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:

• Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide

• Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)

Exclusion Criteria:

• Target Disease Exceptions

• Plasma cell leukemia

• Monoclonal gammopathy of undetermined significance (MGUS)

• Smoldering Myeloma

• Primary amyloidosis

• Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome