MedTrace Logo

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

NCT01897714 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-10-23

Study results available
· View outcomes & findings →

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

  • Relapsed and/or Relapsed-refractory Multiple Myeloma

Interventions

DRUG

Melflufen

DRUG

Dexamethasone

Sponsors & Collaborators

  • Oncopeptides AB

    lead INDUSTRY

Principal Investigators

  • Paul G Richardson, MD · Dana Farber Cancer Institute, Boston MA, USA

  • Johan Harmenberg, MD · Oncopeptides AB, Stockholm, Sweden

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-12-31
Completion
2020-03-31

Countries

  • United States
  • Denmark
  • Italy
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT01897714 on ClinicalTrials.gov