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PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function

NCT03639610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-03-10

Study results available
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Summary

This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function.

Conditions

Interventions

DRUG

Melflufen

Melflufen was distributed in the European Union (EU) as a powder for concentrate for solution for infusion; in the US, it was distributed as a powder for injection. Melflufen was administered as a 30-minute intravenous infusion on Day 1 of every 28-day cycle via a central catheter.

DRUG

Dexamethasone

Tablets. Administered orally on Days 1, 8, 15, and 22 of each 28-day cycle. Dose of 40 mg for patients aged \<75 years. Dose of 20 mg for patients aged ≥75 years.

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
2018-08-28
Primary Completion
2021-12-22
Completion
2021-12-22
FDA Drug
Yes

Countries

  • Czechia
  • Greece
  • Poland

Study Locations

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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 NCT03639610 on ClinicalTrials.gov