Status:
COMPLETED
A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment
Lead Sponsor:
Janssen-Cilag Ltd.
Collaborating Sponsors:
Legend Biotech
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
- Received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response)
- Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
- Must not be pregnant or must not plan to become pregnant within the study period
Exclusion
Key Trial Info
Start Date :
August 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04035226
Start Date
August 2 2019
End Date
October 27 2022
Last Update
March 30 2025
Active Locations (75)
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1
Oncology Institute of Hope and Innovation
Glendale, California, United States, 91204
2
Marin Cancer Center
Greenbrae, California, United States, 94904
3
Asclepes Research
Weeki Wachee, Florida, United States, 34607
4
Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.
Peoria, Illinois, United States, 61615