Early Patient Access Treatment Use Protocol CA204-220

NCT ID: NCT02856438

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Interventions

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Elotuzumab

Specified dose on specified days

Intervention Type DRUG

Lenalidomide

Specified dose on specified days

Intervention Type DRUG

Dexamethasone

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-901608

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Shibukawa-shi, Gunma, Japan

Site Status

Local Institution

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA204-220

Identifier Type: -

Identifier Source: org_study_id