Clinical Trials Directory

Trials / Terminated

TerminatedNCT01897714

Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

An Open-Label Phase I/IIa Study of the Safety and Efficacy of Melphalan-flufenamide (Melflufen) and Dexamethasone Combination for Patients With Relapsed and/or Relapsed-Refractory Multiple Myeloma

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Oncopeptides AB · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The study will explore escalating doses of melflufen in combination with dexamethasone in small groups of patients to find the maximum tolerated dose of melflufen. That dose will then be used to determine the efficacy and safety profile of melflufen in combination with dexamethasone in a larger group of patients.

Conditions

Interventions

TypeNameDescription
DRUGMelflufen
DRUGDexamethasone

Timeline

Start date
2013-07-01
Primary completion
2017-12-01
Completion
2020-03-01
First posted
2013-07-12
Last updated
2020-10-23
Results posted
2020-08-24

Locations

7 sites across 5 countries: United States, Denmark, Italy, Netherlands, Sweden

Source: ClinicalTrials.gov record NCT01897714. Inclusion in this directory is not an endorsement.