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A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide

NCT03151811 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2024-01-30

Study results available
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Summary

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with RRMM following 2-4 lines of prior therapy and who were refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients received either melflufen+dex or pomalidomide+dex.

Conditions

Interventions

DRUG

Melflufen

Intravenous infusion

DRUG

Pomalidomide

Oral capsules

DRUG

Dexamethasone

Oral tablets

Sponsors & Collaborators

  • Oncopeptides AB

    lead INDUSTRY

Principal Investigators

  • Pieter Sonneveld, Prof. · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2021-02-03
Completion
2023-02-03
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

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 NCT03151811 on ClinicalTrials.gov