An observational study in Multiple Myeloma, sponsored by iOMEDICO AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by iOMEDICO AG · Observational
Multiple myeloma is the second most common hematologic malignancy in adults and despite the new therapies that have been developed in the last decades it remains incurable. Over the course of the disease, patients eventually become refractory to the various treatments. Therefore, new therapeutic options which utilize new mechanisms of action are essential.
Melphalan flufenamide (melflufen) represents such an additional therapeutic approach. Melflufen is a peptide-drug conjugate (PDC) which is highly lipophilic and rapidly incorporated into the tumor cells. Once inside the tumor cell, melflufen is hydrolyzed by peptidases, including aminopeptidases and esterases, to release its alkylator payload. The alkylating agent then induces DNA damage resulting in cell death.
Melphalan flufenamid in combination with Dexamethason was approved by the European Medicines Agency (EMA) in August 2022 for the treatment of patients with triple class refractory relapsed/refractory Multiple Myeloma who have received at least 3 prior lines of therapy. For patients with prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
The non-interventional study MARINA aims to address open scientific questions regarding the effectiveness, as well as therapy and safety management of melflufen in a real-world setting. By collecting comprehensive real-world data - including the Disease Control Rate (DCR) as a key endpoint, which is of most value for patients in this late disease stage - MARINA will investigate the therapeutic benefit of melflufen in routine clinical practice.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →iOMEDICO AG is the lead sponsor of 53 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years old) with relapsed and/or refractory multiple myeloma (R/RMM) pretreated with a proteasome inhibitor, an immunomodulatory drug and a CD38 antibody with decision for treatment with melflufen (Pepaxti®) and dexamethasone in fourth or later line according to SmPC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥18 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Disease control rate (DCR)
DCR is defined as the proportion of patients achieving a remission (i.e., sCR, CR, VGPR or PR or MR) or stable disease as best response according to local medical standards during treatment with melflufen. Patients without response measurement are considered non-responders.
Time frame: max. 38 months (FPI - LPLV)
Progression-free survival (PFS)
PFS is defined as the time from start of melflufen treatment until first progression or death from any cause, whichever comes first. Patients without disease progression or death at the time of analysis will be censored at their date of last contact. PFS will be calculated using the Kaplan-Meier method.
Time frame: max. 38 months (FPI - LPLV)
Overall survival (OS)
OS is defined as the time from start of melflufen treatment until death from any cause. Patients without documented death will be censored with their date of last contact. OS will be calculated using the Kaplan-Meier method.
Time frame: max. 38 months (FPI - LPLV)
Overall response rate (ORR)
ORR is defined as the proportion of patients achieving a remission (sCR, CR, VGPR or PR or MR) as best response according to local medical standards. Patients without response measurement are considered non-responders.
Time frame: max. 38 months (FPI - LPLV)
Duration of treatment with melflufen
Duration of melflufen treatment will be calculated in weeks as the time from first application to the last documented application of melflufen.
Time frame: max. 38 months (FPI - LPLV)
Clinical benefit rate (CBR)
CBR is defined as the proportion of patients achieving a sCR, CR, VGPR, PR or MR as best response according to local medical standards during treatment with melflufen. Patients without response measurement are considered non-responders.
Time frame: max. 38 months (FPI - LPLV)
Time to next treatment (TTNT)
TTNT is defined as the time from start of melflufen treatment until start of the following therapy line or death, whichever comes first. Patients alive and without subsequent treatment at the time of analysis will be censored at their date of last contact. TTNT will be calculated using the Kaplan-Meier method.
Time frame: max. 38 months (FPI - LPLV)
PFS2
PFS2 is defined as the time from start of melflufen treatment until progression or death during first subsequent treatment line, whichever comes first. If subsequent line is not reached, previous-line death will serve as event. Patients without progression after the start of the subsequent line or death at the time of analysis will be censored at their date of last contact. PFS2 will be calculated using the Kaplan-Meier method.
Time frame: max. 38 months (FPI - LPLV)
PFS of first subsequent treatment line
PFS of first subsequent treatment line is defined as time from start of first subsequent treatment line until first progression thereafter, or death from any cause, whatever comes first. Patients without progression or death at the time of analysis will be censored with their date of last contact. PFS of first subsequent treatment line will be calculated using the Kaplan-Meier method.
Time frame: max. 38 months (FPI - LPLV)
(Serious) adverse events ((S)AE)
The case- and patient-based incidence of (S)AEs will be provided.
Time frame: max. 38 months (FPI - LPLV)
(Serious) adverse drug reactions ((S)ADR) related to melphalan flufenamid
The case- and patient-based incidence of (S)ADRs will be provided.
Time frame: max. 38 months (FPI - LPLV)
Types of treatments prior to Melflufen
To illustrate the prior treatments, the substances administered before Melflufen are listed by treatment line.
Time frame: max. 38 months (FPI - LPLV)
Melfalan flufenamid starting dose
Frequencies of patients with specific melflufen starting dose (i.e., 40mg, 30mg, other) will be provided.
Time frame: max. 38 months (FPI - LPLV)
Absolute dose intensity of melphalan flufenamid
Absolute dose intensity of melphalan flufenamid will be displayed with descriptive statistics.
Time frame: max. 38 months (FPI - LPLV)
Relative dose intensity of melphalan flufenamid
Relative dose intensity of melphalan flufenamid will be displayed with descriptive statistics.
Time frame: max. 38 months (FPI - LPLV)
Type of dose modifications
Type of dose modifications will be displayed with descriptive statistics.
Time frame: max. 38 months (FPI - LPLV)
Frequency of dose modifications
Frequency of dose modifications will be displayed with descriptive statistics.
Time frame: max. 38 months (FPI - LPLV)
Reasons for dose modifications
Reasons for dose modifications will be displayed with descriptive statistics.
Time frame: max. 38 months (FPI - LPLV)
Substances of subsequent antineoplastic treatment
Frequencies of substances used will be displayed in a summary table.
Time frame: max. 38 months (FPI - LPLV)
Global health-related quality of life during course of treatment
The change from baseline (i.e., difference) in the scales of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer quality of life questionnaire C30) will be displayed for each point in time, using boxplots.
Time frame: max. 38 months (FPI - LPLV)
Multiple myeloma related quality of life during course of treatment
The change from baseline (i.e., difference) in the scales of the EORTC QLQ-MY20 (European Organisation for Research and Treatment of Cancer quality of life questionnaire MY20) will be displayed for each point in time, using boxplots.
Time frame: max. 38 months (FPI - LPLV)
Assessing parameters of physician treatment decision making
Results of therapy decision questionnaires will be displayed with frequencies in a summary table.
Time frame: max. 38 months (FPI - LPLV)
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