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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02856438
Other study ID # CA204-220
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date December 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Elotuzumab
Specified dose on specified days
Lenalidomide
Specified dose on specified days
Dexamethasone
Specified dose on specified days

Locations

Country Name City State
Japan Local Institution Nagoya-shi Aichi
Japan Local Institution Nagoya-shi Aichi
Japan Local Institution Osaka-shi Osaka
Japan Local Institution Shibukawa-shi Gunma

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb AbbVie

Country where clinical trial is conducted

Japan, 

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