Early Patient Access Treatment Use Protocol CA204-220

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

No longer available

CT.gov ID

NCT02856438

Collaborator

AbbVie (Industry)

Locations

Study Details

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 Japanese sites where licensed physicians determine clinical need.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Elotuzumab Drug: Lenalidomide Drug: Dexamethasone

Study Design

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 in Japan

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

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:

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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Nagoya-shi	Aichi	Japan	4600001
2	Local Institution	Nagoya-shi	Aichi	Japan	4678602
3	Local Institution	Shibukawa-shi	Gunma	Japan	3770280
4	Local Institution	Osaka-shi	Osaka	Japan	5438555