Early Patient Access Treatment Use Protocol CA204-220

Bristol-Myers Squibb (BMS)

Status

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Elotuzumab; Drug: Dexamethasone

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02856438

CA204-220

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 Japanese sites where licensed physicians determine clinical need.

Sex: All

Ages: 20+ 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 20 years and older.

• Active, relapsed or refractory multiple myeloma by International Myeloma Working Group (IMWG) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy.

• Progression from a most recent line of 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 enrollment.

ii) Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.

Exclusion Criteria

• 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.
• Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
• Other protocol-defined Inclusion/Exclusion criteria apply.