Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Completed · Phase 3

Conditions studied: Lymphoma, Multiple Myeloma

In brief

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

Key facts

Study ID

NCT01239797

Run by

Bristol-Myers Squibb

People needed

646

Starts

2011-06-20

Expected to finish

2021-04-21

Last updated by the study team

2022-06-01

Who can join

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

You may qualify if…

• Documented progression from most recent line of therapy
• 1-3 prior lines of therapy
• Measurable disease
• Life expectancy ≥3 months
• Prior treatment with Lenalidomide permitted if:
• Best response achieved was ≥Partial Response (PR)
• Patient was not refractory
• Patient did not discontinue due to a Grade ≥3 related adverse event
• Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

You may not qualify if…

• Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
• Active plasma cell leukemia
• Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Where it is running

• Acrc/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Local Institution — Berkeley, California, United States
• Local Institution — Burbank, California, United States
• Compassionate Cancer Res Grp — Corona, California, United States
• Local Institution — Corona, California, United States
• San Diego Pacific Oncology& Hematology Associates, Inc — Encinitas, California, United States
• Local Institution — Greenbrae, California, United States
• Ucla-Division Of Hematology/Oncology — Los Angeles, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Local Institution — Vallejo, California, United States
• Local Institution — Boca Raton, Florida, United States
• Cancer Care Centers Of Florida — Brooksville, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Local Institution — New Port Richey, Florida, United States
• Cancer Institute Of Florida — Orlando, Florida, United States
• Local Institution — Titusville, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Winship Cancer Institute. — Atlanta, Georgia, United States
• Georgia Health Science University — Augusta, Georgia, United States
• Orchard Healthcare Research Inc. — Skokie, Illinois, United States
• Local Institution — Indianapolis, Indiana, United States
• Local Institution — Mishawaka, Indiana, United States
• Local Institution — Iowa City, Iowa, United States
• Northwest Alabama Cancer Center, Pc — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.