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NCT02856438 Clinical Trial

Early Patient Access Treatment Use Protocol CA204-220

Multiple Myeloma Clinical Trial

Official title:
An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan

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, 

See also
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Recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

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