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A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

NCT02963493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2022-11-22

Study results available
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Summary

This study will evaluate melflufen in combination with dexamethasone in adult patients with relapsed or refractory multiple myeloma in whose disease is refractory to pomalidomide and/or an anti-CD38 monoclonal antibody. All patients in the study will be treated with melflufen on Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.

Conditions

Interventions

DRUG

Melphalan flufenamide (Melflufen)

DRUG

Dexamethasone

IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.

Sponsors & Collaborators

  • Precision For Medicine

    collaborator INDUSTRY

  • Oncopeptides AB

    lead INDUSTRY

Principal Investigators

  • Johan Harmenberg, MD, PhD · Oncopeptides AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2020-10-22
Completion
2021-11-16

Countries

  • United States
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02963493 on ClinicalTrials.gov