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Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma

NCT04649060 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-06-08

Study results available
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Summary

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI.

Patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.

Conditions

  • Relapsed Multiple Myeloma
  • Relapsed-Refractory Multiple Myeloma

Interventions

DRUG

Melflufen

Powder for solution for i.v. infusion

DRUG

Dexamethasone

Oral tablets

DRUG

Daratumumab

Solution for s.c. injection

Sponsors & Collaborators

  • Oncopeptides AB

    lead INDUSTRY

Principal Investigators

  • Maria-Victorìa Mateos, MD, PhD · Complejo Hospitalario de Salamanca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2022-02-07
Completion
2022-02-07
FDA Drug
Yes

Countries

  • Bulgaria
  • Czechia
  • Georgia
  • Germany
  • Greece
  • Norway
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine

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 NCT04649060 on ClinicalTrials.gov