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

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT02159365

Run by

Bristol-Myers Squibb

People needed

84

Starts

2014-03-08

Expected to finish

2018-07-11

Last updated by the study team

2019-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Acrc/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Highland Oncology Group — Fayetteville, Arkansas, United States
• Comprehensive Blood And Cancer Center — Bakersfield, California, United States
• California Cancer Associates for Research and Excellence — Encinitas, California, United States
• Compassionate Cancer Res Grp — Fountain Valley, California, United States
• Robert A. Moss, Md Facp, Inc. — Fountain Valley, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Pacific Cancer Care — Monterey, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Wellness Oncology & Hematology — West Hills, California, United States
• James R. Berenson, MD, Inc. — West Hollywood, California, United States
• Rocky Mountain Cancer Centers Llp — Denver, Colorado, United States
• Cancer Specialists Of North Florida — Jacksonville, Florida, United States
• Center For Cancer Care & Research — Lakeland, Florida, United States
• Baptist Health Medical Group Oncology — Miami, Florida, United States
• Oncology Specialists,S.C — Park Ridge, Illinois, United States
• Investigative Clinical Research Of Indiana, Llc — Indianapolis, Indiana, United States
• Horizon Oncology Research, Inc — Lafayette, Indiana, United States
• Clinical Research Alliance, Inc. — New York, New York, United States
• St Francis Hospital — Greenville, South Carolina, United States
• Greenville Health System — Greenville, South Carolina, United States
• Texas Oncology — Dallas, Texas, United States
• Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Local Institution — Houston, Texas, United States
• Cancer Centers of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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