sEAPort: Expanded Access Program

A Multicenter Expanded Access Program Protocol for Melflufen (Melphalan Flufenamide) in Combination with Dexamethasone in Patients with Triple-Class Refractory Multiple Myeloma.

Melflufen is an investigational agent and not currently approved by the US FDA.

Overview:

A multicenter, open-label expanded access program (EAP) protocol to address an unmet medical need by providing access to melflufen for patients with triple class refractory multiple myeloma who:

  • Have received at least two prior lines of therapy

-and-

  • Are triple-class refractory or intolerant to at least:
    • one proteasome inhibitor (PI)
    • one immunomodulatory drug (IMiD) and
    • one anti-CD38 antibody (Anti-CD38 mAb)

Planned Timing:

Oncopeptides is currently planning for a late summer start for sEAPort.

sEAPort (OP-110): Study Design

Multicenter Expanded Access Program Protocol for Melflufen (Melphalan Flufenamide) in Combination with Dexamethasone in US Patients with Triple-Class Refractory Multiple Myeloma [OP-110].

Primary Endpoint: 

Safety and Tolerability (Serious Adverse Events and non-serious events of Grade ≥3)

Secondary Endpoint:

Overall Response Rate (investigator assessed)

Exploratory (Voluntary) Endpoint:

Multiple myeloma-associated pain and quality of life based on patient reported outcome

 

**Optional assessments (CBC, Vital signs, PE) at Day 8, 15 and 22

Protocol finalization anticipated June, 2020.  FPI anticipated summer 2020

 

sEAPort (OP-110): Key Criteria

Key Inclusion Criteria*

  • Triple-class refractory multiple myeloma.
    • TCR defined as refractory to at least one PI, at least one IMiD, and at least one Anti-CD38 mAb. Refractory status includes patients who have a non-responsive disease or progress within 60 days of last therapy. Non-responsive disease is defined as either failure to achieve minimal response, i.e. stable disease (SD) was best response, or development of progressive disease while on therapy
    • Refractory definition also includes intolerance to PI/IMiD/Anti CD38 as per investigator
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Adequate baseline hematologic and organ function
    • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
    • Platelet count ≥ 75,000 cells/mm3
    • Estimated glomerular filtration rate (eGFR) of ≥ 45 mL/min
  • Accepts having a central port-a-cath, peripherally inserted central catheter (PICC) line, or central venous catheter for infusion of melflufen
  • Has not been enrolled in another melflufen study and is not eligible for or does not have access to enroll in another ongoing clinical study of melflufen

*Key eligibility criteria listed and is not all inclusive

 

Key Exclusion Criteria*

  • Primary refractory disease, i.e. never responded (according to International Myeloma Working Group) to any prior therapy
  • Known to be platelet transfusion refractory
  • Any medical conditions that, in the Investigator’s opinion, would impose excessive risk to the patient
  • Known central nervous system (CNS) or meningeal involvement of myeloma
  • Prior stem cell transplant (autologous and/or allogeneic) within 6 months of initiation of therapy
  • Prior allogeneic stem cell transplant with active graft-versus-host- disease (GVHD)
  • Prior treatment with melflufen

*Key eligibility criteria listed and is not all inclusive

 

More Information

For more information on Melflufen contact the Medical Information department directly by phone at  1-866-522-8894 or by email at medinfo@oncopeptides.com

Melflufen is an investigational agent and not currently approved by the US FDA.