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PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Study of the Pharmacokinetics of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma and Impaired Renal Function

NCT03639610•Oncopeptides AB

View on ClinicalTrials.gov

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.

Detailed Description

This was a multicenter study assessing the safety, tolerability, and efficacy of melflufen given on Day 1 of a 28-day cycle, together with weekly dexamethasone, in patients with relapsed multiple myeloma or RRMM and impaired renal function, as well as the relationship between renal function and PK parameters for the active metabolite melphalan.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, age 18 years or older, at the time of signing the informed consent;
•2. A prior diagnosis of multiple myeloma (MM) with documented disease progression in need of treatment at time of screening;
•3. Received at least 2 prior lines of therapy;
•4. Measurable disease defined as any of the following:
•* Serum monoclonal protein ≥0.5 g/dL by serum protein electrophoresis (SPEP).
•* ≥200 mg/24 hours of monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP)
•* Serum free light chain (SFLC) ≥10 mg/dL AND abnormal serum kappa to lambda free light chain ratio
•5. Life expectancy of ≥6 months;
•6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. (Patients with lower performance status based solely on bone pain secondary to MM may be eligible following consultation and approval of the medical monitor);
•7. Patient is a female of childbearing potential (FCBP)\* with a negative serum or urine pregnancy test prior to initiation of therapy and agrees to practice appropriate methods of birth control, or the patient is male and agrees to practice appropriate methods of birth control;
+16 more criteria

Exclusion Criteria

•1. Primary refractory disease (i.e., never responded with ≥ minimal response \[MR\] to any prior therapy);
•2. Evidence of mucosal or internal bleeding and/or platelet transfusion refractory (platelet count fails to increase by \>10,000 cells/mm³ \[10.0 x 10⁹/L\] after a transfusion of an appropriate dose of platelets);
•3. Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ≥Grade 3 thromboembolic event in the last 6 months);
•4. Known active infection requiring parenteral or oral anti-infective treatment within 14 days of initiation of therapy;
•5. Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance;
•6. Pregnant or breast-feeding females;
•7. Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation;
•8. Known human immunodeficiency virus or active hepatitis B or C viral infection;
•9. Concurrent symptomatic amyloidosis or plasma cell leukemia;
•10. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes);
+8 more criteria

Locations (10)

University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

Brno, Czechia

University Hospital Olomouc, Clinic of Hemato-Oncology

Olomouc, Czechia

General University Hospital in Prague, 1st Internal Clinic - Clinic of Hematology

Prague, Czechia

General Hospital of Athens "Evangelismos"

Athens, Greece

General Hospital of Athens Alexandra, Therapeutic Clinic

Athens, Greece

University General Hospital of Patras

Pátrai, Greece

Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka

Torun, Torun, Poland

Maria Sklodowska-Curie Institute of Oncology, Branch in Gliwice, Department of Bone Marrow Transplantation and Hematologic Oncology

Gliwice, Poland

Independent Public Healthcare Facility Municipal Hospitals, Department of Hematology

Katowice, Poland

Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy

Lublin, Poland

Key Dates

Start Date

August 28, 2018

Primary Completion Date

December 22, 2021

Completion Date

December 22, 2021

Last Updated

March 10, 2023

Enrollment

ACTUAL participants

Conditions

Renal ImpairmentMultiple Myeloma

Interventions

Melflufen

DRUG

Dexamethasone

DRUG

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

NCT06179888

Multiple Myeloma

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RECRUITINGPHASE3

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

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RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma