Expanded Access Treatment Protocol CA204-143

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ClinicalTrials.gov Identifier: NCT02368301

Expanded Access Status : Approved for marketing

First Posted : February 23, 2015

Last Update Posted : October 6, 2016

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

Study Description

Brief Summary:

The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.

Condition or disease	Intervention/treatment
Multiple Myeloma	Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone

Study Design

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Study Type :	Expanded Access
Official Title:	An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Lenalidomide Elotuzumab

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All

Criteria

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

Inclusion Criteria:

Men and women 18 years and older
Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy
Prior lenalidomide exposure is permitted only if they fulfill all of the following:
- i)Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrolment.
- ii) Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE

Exclusion Criteria:

Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2
Significant cardiac disease as determined by the treating physician including cardiac amyloidosis
HIV infection or active hepatitis A, B, or C
History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009
Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD)
Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient
Certain abnormal physical or laboratory findings
Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368301

Show 25 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

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Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

EAP Investigator Requests This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

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Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT02368301 History of Changes
Other Study ID Numbers:	CA204-143
First Posted:	February 23, 2015 Key Record Dates
Last Update Posted:	October 6, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:

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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	Dexamethasone acetate Lenalidomide Elotuzumab BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents

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