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Relapse Multiple MyelomaPhase 2NCT06682637

Melflufen for Elderly Patients With Relapsed Myeloma

A Phase 2 study testing Melflufen and Dexamethasone in people with Relapse Multiple Myeloma, run by Fondazione EMN Italy Onlus at 10 sites in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a pilot study aimed to evaluate the efficacy and tolerability of melflufen plus dexamethasone in elderly patients at second relapse. Thirty elderly patients at second or subsequent relapse. Read more about this study

Who is it for?
Ages 70 to 80 years
Conditions the study is for
Relapse Multiple Myeloma
What is being tested?
Melflufen and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
10 sitesItaly
Study dates
26 Mar 2025to 26 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients affected by MM progressed or relapsed after 2 or more previous lines of therapy.
  • 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.
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  • 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.
  • Adequate hepatic function characterized by the following:
  • oTotal bilirubin ≤1.5 x ULN. oAST ≤2.5 x ULN oALT ≤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:
  • Absolute neutrophil count ≥1.0 × 109/L (use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing).
  • Platelet count ≥50 × 109/L (transfusion support is not permitted).
  • Hemoglobin ≥8 g/dL (transfusion support is permitted).
  • Non-vasectomized male patients agree to practice appropriate methods of birth control

Who cannot join

  • 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.
  • 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 eligibility confirmation, and considered at substantial risk of relapse in the following 12 months.
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  • 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:
  • Myocardial infarction within 6 months before trial eligibility
  • Uncontrolled disease/condition related to or affecting cardiac function (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV)
  • Clinically significant ECG abnormalities.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Italy10 sites

  • A.O.U. delle Marche

    Ancona

  • Ospedale Nuovo di Legnano

    Legnano

  • Ospedale Niguarda

    Milan

  • Ospedale S. Carlo Borromeo

    Milan

  • Policlinico Giaccone Divisione Ematologia e Centro Trapianti di Midollo

    Palermo

  • A.O.U. di Parma

    Parma

  • A.O.U. Pisana

    Pisa

  • I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • A.O.U. Città della Salute e della Scienza di Torino-SSD Clinical trials

    Torino

  • Ospedale S. Maria della Misericordia di Udine

    Udine

Other trials in Italy

About this study

Official title: Melflufen for Elderly Myeloma Patients in Second or Subsequent Relapse

This is a pilot study aimed to evaluate the efficacy and tolerability of melflufen plus dexamethasone in elderly patients at second relapse.

Thirty elderly patients at second or subsequent relapse.

Being tested
Melflufen, Dexamethasone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelflufenDrug

    Pepaxti 20 mg powder for concentrate for solution for infusion

  • DexamethasoneDrug

    SOLDESAM 8 mg/2 ml solution for injection SOLDESAM 0.2% oral drops, solution

Study groups in NCT06682637
Study groupRoleWhat they receive
Melflufen and DexamethasoneExperimental* Melflufen 40 mg total dose (30 mg in patients with body weight ≤60 kg and/or in patients with eGFR<45 mL/min) intravenously on day 1. * Dexamethasone 10 mg orally or intravenously on day 1-2, 8-9, 15-16, 22-23.
Receives: Drug: Melflufen; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    rate of participants who achieve a PR or better (PR+VGPR+CR+sCR) according to IMWG response criteria during the treatment.

    Measured: approximately 6 months after the enrolled of the last participant and an updated analysis will be conducted at approximately 8 to 12 months.

Secondary outcomes (6)

  1. DURATION OF RESPONSE

    the time from the date of first documented response (≥PR) to the date of first confirmed PD.

    Measured: after 2.5 years

  2. PROGRESSION-FREE SURVIVAL

    the time from the date of 1st dose of study drug to the date of first confirmed PD or death due to any cause, whichever occurs first.

    Measured: after 6 months

  3. TIME TO PROGRESSION

    the time from the date of 1st dose of study drug to the date of first documented PD

    Measured: after 2.5 years

  4. PROGRESSION-FREE SURVIVAL 2

    the time from the date of 1st dose of study drug to the date of event, which is defined as death from any cause or PD that starts after the next line of therapy, whichever occurs first.

    Measured: after 2.5 years

  5. OVERALL SURVIVAL

    the time from the date of 1st dose of study drug to the date of death.

    Measured: after 2.5 years

  6. TIME TO RESPONSE

    the time from the date of 1st dose of study drug to the first documented response (≥PR).

    Measured: after 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start26 Mar 2025
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

Why it stopped: Clinical trial never activated, not authorized by CA

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Treatment consists in 28-day cycles: * Melflufen 40 mg total dose (30 mg in patients with body weight ≤60 kg and/or in patients with eGFR\<45 mL/min) intravenously on day 1. * Dexamethasone 10 mg orally or intravenously on day 1-2, 8-9, 15-16, 22-23. Cycles are repeated until clinical relapse or progression, or unacceptable toxicity.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682637
Sponsor's protocol ID
MELISSA
Status last verified
Mar 2025
First submitted
8 Nov 2024
Last updated
1 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melflufen and Dexamethasone in people with Relapse Multiple Myeloma, run by Fondazione EMN Italy Onlus at 10 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: approximately 6 months after the enrolled of the last participant and an updated analysis will be conducted at approximately 8 to 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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