Clinical Trials Logo

Clinical Trial Summary

Phase 1 The primary objectives of Phase 1 of this study are to: - Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen. - Identify the recommended Phase 2 dose (RP2D) of tinostamustine for use in the Phase 2 portion of the study. The secondary objective of Phase 1 of this study is to: - Investigate the pharmacokinetics (PK) of tinostamustine.


Clinical Trial Description

Study Design (Methodology): This is a 2-part, international, multi-center, open-label study of salvage treatment with tinostamustine conditioning followed by ASCT in participants with relapsed/ refractory multiple myeloma (MM). (ASCT is defined as salvage if the participant had already received a prior ASCT and undergoes a second ASCT after evidence of progressive disease [PD].) Phase 1 of the study employs a standard 3+3 dose escalation design with the objective of defining the dose limiting toxicities (DLTs) of the tinostamustine conditioning regimen and defining the MTD and RP2D for use in the Phase 2 portion of the study. The Safety Review Committee can make a decision to stop dose escalation or explore intermediary doses at any time. The total dose of tinostamustine will be administered on Day -1. Phase 2 of the study employs a 2-step sequential design (Simon, 1989). In Stage 1 of Phase 2, up to 31 participants initially will be enrolled. If lesser than or equal to (<=) 25 participants of these initial 31 participants experience a response, then no additional participants will be enrolled. However, if greater than (>) 25 participants in Stage 1 of Phase 2 experience a response, then enrollment in this cohort will continue, with up to 71 participants enrolled. In Phase 2 of the study, all participants will receive tinostamustine at the RP2D administered in Phase 1 according to the same schedule. After provision of written informed consent, participants will be screened for study eligibility within 28 days before Day 1 (the day of ASCT). Participants who have a minimum of 2×106 CD34+ cells/kg cryopreserved and are otherwise determined to be eligible, based on screening assessments, will be enrolled and receive the tinostamustine conditioning regimen. The tinostamustine dose will be administered 24 hours pre-ASCT (i.e., Day -1). On Day 1, ASCs will be administered intravenously (IV) according to standard institutional practice. Participants will receive supportive measures (including growth factor support post-ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion, and treatment for neutropenic fever) according to standard institutional practice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03687125
Study type Interventional
Source Mundipharma-EDO GmbH
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date October 15, 2018
Completion date April 17, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01435720 - Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL) Phase 1/Phase 2
Recruiting NCT04094961 - Ixazomib + Pomalidomide + Dexamethasone In MM Phase 1/Phase 2
Recruiting NCT06068400 - Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Multiple Myeloma N/A
Recruiting NCT03601624 - Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans Phase 2
Recruiting NCT05020444 - TriPRIL CAR T Cells in Multiple Myeloma Phase 1
Not yet recruiting NCT03706547 - Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM Phase 1
Active, not recruiting NCT02970747 - Non-interventional Study of Kyprolis® in Combination With Revlimid® and Dexamethasone or Dexamethasone Alone or in Combination With Darzalex® and Dexamethasone in Multiple Myeloma Patients
Completed NCT01965353 - A Phase I Study Of Panobinostat/Lenalidomide/Bortezomib/Dex for Relapsed And Relapsed/Refractory Multiple Myeloma Phase 1
Not yet recruiting NCT05581875 - A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory Phase 1/Phase 2
Recruiting NCT06282978 - Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes Phase 2
Recruiting NCT06158412 - All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma Phase 2
Active, not recruiting NCT03030261 - Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma Phase 2
Recruiting NCT04925193 - Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma Phase 2
Recruiting NCT05121103 - A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma Phase 1
Recruiting NCT04603872 - CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies Early Phase 1
Recruiting NCT04657861 - APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma Early Phase 1
Terminated NCT05191472 - Pembrolizumab for the Treatment of Relapsed or Refractory Multiple Myeloma After Anti-BCMA CAR-T Therapies Phase 2
Completed NCT03136653 - A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma Phase 1/Phase 2
Recruiting NCT04162353 - BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma Phase 1
Recruiting NCT04176718 - Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM Phase 2