An Expanded Access Program Protocol for Melphalan Flufenamide (melflufen) in Combination with Dexamethasone in Patients with Triple Class Refractory Multiple Myeloma SEAPORT

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.

The sites listed below are not the only locations where patients may be able to participate. If you are interested and deemed eligible for the study, Oncopeptides may work with a local oncologist to bring this program to a center near you. Please contact SparkCures at (888) 828-2206 for additional assistance.

This trial is currently open and accepting patients.

What's being studied?

  • Dexamethasone is a steroid given in conjunction with some cancer treatments.
  • Melphalan Flufenamide (Melflufen) is a 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)

View More

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

Published Results

Full data set of Oncopeptides phase 2 HORIZON study in multiple myeloma published in the Journal of Clinical Oncology

December 09, 2020

The phase 2 HORIZON data are the basis for the ongoing priority review of the New Drug Application to the US Food and Drug Administration FDA, for accelerated approval of melflufen in combination with dexamethasone in triple-class refractory multiple myeloma patients, who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody.

Oncopeptides AB

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.

All Trial Locations

View all clinical trial locations sorted by state.


Highlands Oncology Group

Fayetteville, AR

Open and Accepting


Beacon Cancer Care

Coeur d'Alene, ID

Open and Accepting


University of Illinois at Chicago

Chicago, IL

Open and Accepting


Gabrail Cancer Center Research

Canton, OH

Open and Accepting

South Carolina

Prisma Health

Greenville, SC

Open and Accepting


Community Cancer Trials of Utah

Ogden, UT

Open and Accepting


Virginia Cancer Specialists

Fairfax, VA

Open and Accepting


Northwest Medical Specialties

Puyallup, WA

Open and Accepting

Trial Resources

Patient Access Transforming Health (PATH)

March 04, 2021

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

Learn more
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message

SparkCures Verified

SparkCures is working closely with Oncopeptides AB to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors