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
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:March 8, 2014
End Date:July 11, 2018

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A Phase 2 Single Arm 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

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


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
We found this trial at
29
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Bakersfield, California 93309
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Blacksburg, Virginia 24060
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Denver, Colorado 80218
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Fayetteville, Arkansas 72703
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Fountain Valley, California 92708
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Fountain Valley, California 92708
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Greenville, South Carolina 29601
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Greenville, South Carolina 29615
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Houston, Texas 77030
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Indianapolis, Indiana 46254
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Jacksonville, Florida 32256
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Lafayette, Indiana
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Lakeland, Florida 33805
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Loma Linda, California 92354
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Monterey, California 93940
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New York, New York 10021
480
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Olympia, Washington 98502
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2017
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Park Ridge, Illinois 60068
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San Antonio, Texas 78229
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West Hills, California
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West Hollywood, California 90069
1978
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