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Bristol-Myers Squibb

Early Patient Access Treatment Use Protocol CA204-220

Official Title: 
An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan
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 Japanese sites where licensed physicians determine clinical need.
Available
Multiple Myeloma

Drug: Elotuzumab
Specified dose on specified days
Other Name: BMS-901608

Drug: Lenalidomide
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days

Eligibility Criteria: 

For more information regarding Bristol-Myers Squibb 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: 1. 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. 2. 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

- Known 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 could apply

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 20 Years
Countries: 
Japan
Contacts: 

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email:
Clinical.Trials@bms.com

First line of the email MUST contain NCT# and Site #.

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Bristol-Myers Squibb
AbbVie
EA Number: 
MeSH Terms: 
Multiple Myeloma, Neoplasms, Plasma Cell, Dexamethasone, Dexamethasone acetate, Lenalidomide, Elotuzumab, BB 1101
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