Status:
WITHDRAWN
A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma
Lead Sponsor:
Oncopeptides AB
Conditions:
Relapse Multiple Myeloma
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of a single infusion of OPD5 before Autologous Stem Cell Transplant in patients with RRMM. The study will evaluate increasing doses...
Eligibility Criteria
Inclusion
- Male or female, between the ages of 18 years and 70 years at the planned time of study treatment; patients greater than 70 years of age may qualify on a case by case basis
- Diagnosis of multiple myeloma
- Received a previous Autologous Stem Cell Transplantation ( ASCT) (single or tandem) that resulted in disease progression within 24 months
- Received at least 2 prior lines of therapy
- Refractory to previous treatment with a Proteasome Inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-Cluster of Differentiation 38 monoclonal antibody (anti-CD38 mAb)
- Male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose
Exclusion
- Prior treatment with melphalan flufenamide (melflufen) or OPD5
- Any medical condition that may interfere with safety or participation in this study
- Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance
- Prior allogeneic stem cell transplantation or prior salvage ASCT
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04918511
Start Date
May 27 2021
End Date
December 1 2025
Last Update
November 26 2021
Active Locations (3)
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1
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, Czechia, 62500
2
University Hospital Ostrava, Clinic of Hematooncology
Ostrava, Czechia
3
Charles University and General Hospital in Prague, 1st Department of Medicine - Department of Hematology, First Faculty of Medicine
Prague, Czechia