Early Patient Access Treatment Use Protocol CA204-220

NCT02856438 | Unknown

• 1 other identifier: CA204-220
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Myeloma

Interventions

Elotuzumab DRUG

Specified dose on specified days

Also known as: BMS-901608

Lenalidomide DRUG

Specified dose on specified days

Dexamethasone DRUG

Specified dose on specified days

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• AbbVie: collaborator

Study Sites (4)

Local Institution

Nagoya, Aichi-ken, 4600001, Japan

Location

Local Institution

Nagoya, Aichi-ken, 4678602, Japan

Location

Local Institution

Shibukawa-shi, Gunma, 3770280, Japan

Location

Local Institution

Osaka, Osaka, 5438555, Japan

Location

Related Links

• EAP Investigator Requests
• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Myeloma

Interventions

elotuzumab; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

JP (4)