Early Patient Access Treatment Use Protocol CA204-220
Primary Purpose
Multiple Myeloma
Status
No longer available
Phase
Locations
Japan
Study Type
Expanded Access
Intervention
Elotuzumab
Lenalidomide
Dexamethasone
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma
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:
- 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02856438
First Posted
August 2, 2016
Last Updated
November 17, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT02856438
Brief Title
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Elotuzumab
Other Intervention Name(s)
BMS-901608
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Specified dose on specified days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution
City
Shibukawa-shi
State/Province
Gunma
ZIP/Postal Code
3770280
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5438555
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx
Description
EAP Investigator Requests
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Early Patient Access Treatment Use Protocol CA204-220
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