Expanded Access Treatment Protocol CA204-143

Bristol-Myers Squibb (BMS)

Status

Conditions: Multiple Myeloma

Treatments: Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02368301

CA204-143

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

A. 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.
• Other protocol-defined Inclusion/Exclusion criteria apply.