An Expanded Access Program Protocol for Melphalan Flufenamide (melflufen) in Combination with Dexamethasone in Patients with Triple Class Refractory Multiple Myeloma SEAPORT
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What's the purpose of this trial?

The goal for the Expanded Access Program is to address an unmet medical need by providing early access to melflufen treatment for RRMM patients who meet all eligibility criteria.

This trial is currently open and accepting patients.


What's being studied?

  • Dexamethasone is a steroid given in conjunction with some cancer treatments that also has anti-cancer activity.
  • Melphalan Flufenamide (Melflufen) is an investigational peptide-drug conjugate (PDC) that uses specific enzymes that are produced in large amounts by myeloma cells. Once the drug enters the cell, it delivers a toxic payload to attack the cancer cell.

What will happen during the trial?

This expanded access protocol is being made available for up to 200 eligible patients.

This expanded access protocol is organized in 28 day cycles. Patients will receive:

  • Melflufen, intravenously via a central line on Day 1 of each 28 day cycle.
  • Dexamethasone, by mouth on Days 1, 8, 15, and 22 of each 28 day cycle.

Patients may continue to participate in the protocol as long as their myeloma doesn’t get worse, if they don’t experience bad side effects or transfer of the patient to the commercial drug following FDA approval or 90 days following approval, whichever comes first.

Patients may be eligible to receive financial assistance for travel and lodging purposes through Oncopeptides’ partner, Lazarex Cancer Foundation. Patients can find more details on the Lazarex PATH (Patient Access Transforming Health) Program by clicking here or in the Resources section below.


Additional Trial Information

Expanded Access

Enrollment: 200 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

  • Patients must be refractory or intolerant to at least one proteasome inhibitor, immunomodulatory drug, and anti CD-38 antibody. (This is known as Triple Class Refectory Multiple Myeloma)
  • Patients must have received at least two prior lines of therapy, or received at least one PI, at least one IMiD, and at least one Anti-CD38 mAb in their first line treatment.
  • Patients must be willing to have a central catheter placed for intravenous melflufen treatment.
  • Patients must not be known to be platelet transfusion refractory.
  • Patients must have adequate hematological and organ function.
  • Patients must not have had either an allogeneic or autologous stem cell transplant in the past six months.
  • Patients must not have already received melflufen or have access to enroll in another melflufen clinical trial.
  • Key eligibility criteria listed and is not all inclusive
View Additional Criteria

Trial Locations

The Expanded Access Program is not limited to the sites that you find listed below. If you are a patient and do not see your center listed as a participating site below, please contact SparkCures at (888) 828-2206 for additional assistance.

Trial Resources

Patient Access Transforming Health (PATH)

October 20, 2020

Patients may be eligible to receive financial assistance for travel and lodging purposes through Oncopeptides’ partner, Lazarex Cancer Foundation.

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