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Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM

NCT03481556 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-12-19

Study results available
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Summary

This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.

Conditions

Interventions

DRUG

Melphalan flufenamide (Melflufen)

Intravenous infusion

DRUG

Dexamethasone

Oral tablets

DRUG

Bortezomib

Subcutaneous administration

DRUG

Daratumumab

Intravenous infusion

Sponsors & Collaborators

  • Oncopeptides AB

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2022-02-02
Completion
2022-02-02
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • 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 NCT03481556 on ClinicalTrials.gov