A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma
NCT04918511 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2021-11-26
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 of OPD5 to find the best dose and to assess any side effects. Each patient will be assigned to a dose cohort of 3-6 patients to receive one single dose of OPD5. Each patient will be hospitalized for about 14 days from the OPD5 infusion and then have monthly visits to the clinic for 3 months and then every third month until disease progression or starting new myeloma treatment, maximum up to 2 years.
Conditions
- Relapse Multiple Myeloma
- Multiple Myeloma
Interventions
- DRUG
-
OPD5
OPD5 solution for i.v. infusion
Sponsors & Collaborators
-
Oncopeptides AB
lead INDUSTRY
Principal Investigators
-
Sergio Giralt, MD · Memorial Sloan Kettering Cancer Centre, New York City, United States
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-27
- Primary Completion
- 2024-03-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- Czechia
Study Locations
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