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Tinostamustine Conditioning and Autologous Stem Cell

NCT03687125 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-06-18

Study results available
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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.

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma Progression
  • Multiple Myeloma With Failed Remission

Interventions

DRUG

Tinostamustine

Participants received tinostamustine IV injection.

PROCEDURE

Autologous Stem Cell Transplant (ASCT)

Undergo autologous stem cell transplant

Sponsors & Collaborators

  • Mundipharma-EDO GmbH

    lead INDUSTRY

Principal Investigators

  • Parameswaran Hari, MD · Study Chair

  • Dagmar Hess · 2nd Study Chair

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2019-04-17
Completion
2019-04-17
FDA Drug
Yes

Countries

  • United States
  • Norway
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687125 on ClinicalTrials.gov