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MELFLUFEN FOR ELDERLY PATIENTS WITH RELAPSED MYELOMA
EU CTIS ID: 2024-514652-33-00
What this study is testing
Evaluate the efficacy of melflufen plus dexamethasone in elderly patients at second or subsequent relapse.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients affected by MM progressed or relapsed after 2 or more previous lines of therapy
- Adequate hepatic function characterized by the following:
- 1) Total bilirubin ≤1.5 x ULN
- 2) AST ≤2.5 x ULN
- 3) ALT ≤2.5 x ULN
- Estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or per the local institutional standard method)
You likely can't join if
- Previous exposure to chemotherapy (i.e. melphalan, high-dose melphalan and/or cyclophosphamide) with the exception of patients who have received an autologous stem cell transplantion with a progression free survival of at least 36 month
- 1) Myocardial infarction within 6 months before trial eligibility
- 2) Uncontrolled disease/condition related to or affecting cardiac function (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV)
- 3) Clinically significant ECG abnormalities
- Plasma cell leukemia
- Systemic amyloid light chain amyloidosis
See the full eligibility criteria
Who can join
- Patients affected by MM progressed or relapsed after 2 or more previous lines of therapy
- Adequate hepatic function characterized by the following:
- 1) Total bilirubin ≤1.5 x ULN
- 2) AST ≤2.5 x ULN
- 3) ALT ≤2.5 x ULN
- Estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or per the local institutional standard method)
- Adequate BM function characterized by the following:
- 1) Absolute neutrophil count ≥1.0 × 10^9/L (use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing)
- 2) Platelet count ≥50 × 10^9/L (transfusion support is not permitted)
- 3) Hemoglobin ≥8 g/dL (transfusion support is permitted)
- Non-vasectomized male patients agree to practice appropriate methods of birth control
- Patient is, in the investigator’s opinion, willing and able to comply with the study visits and procedures required per protocol
- Patient has provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any study-specific activities or procedures. Subject does not have kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements
- Life expectancy ≥ 3 months
- Previous exposure to, at least, one drug of all the following categories: an anti-CD38 MoAbs, an IMiD, and a proteasome inhibitor
- Age ≥ 70 and ≤ 85 years
- ECOG performance status ≤2
- Subject must have serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours, or serum immunoglobulin involved free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- LVEF ≥40% as determined by a MUGA scan or ECHO
What rules you out
- Previous exposure to chemotherapy (i.e. melphalan, high-dose melphalan and/or cyclophosphamide) with the exception of patients who have received an autologous stem cell transplantion with a progression free survival of at least 36 month
- 1) Myocardial infarction within 6 months before trial eligibility
- 2) Uncontrolled disease/condition related to or affecting cardiac function (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV)
- 3) Clinically significant ECG abnormalities
- Plasma cell leukemia
- Systemic amyloid light chain amyloidosis
- POEMS Syndrome
- Central Nervous System (CNS) disease localization
- Subject with another tumor, not including MM, that required ongoing treatment or therapy completed less than 6 months before, and considered at substantial risk of relapse in the following 12 months
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to eligibility confirmation
- Subject has any concurrent medical condition or disease (e.g. active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
- Subject has clinically significant cardiac disease, including:
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.