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Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma (sEAPort)

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ClinicalTrials.gov Identifier: NCT04534322
Expanded Access Status : Available
First Posted : September 1, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Oncopeptides AB

Tracking Information
First Submitted Date August 26, 2020
First Posted Date September 1, 2020
Last Update Posted Date November 23, 2020
 
Descriptive Information
Brief Title Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma
Brief Summary To provide early treatment access and evaluate the safety of melflufen and dexamethasone in patients with triple class refractory (TCR) multiple myeloma (MM).
Detailed Description This is a multicenter, expanded access program protocol to provide access to melflufen for patients with RRMM in medical need, who have progressive disease after they received a minimum of at least two prior lines of therapy, are triple-class refractory to at least one PI, at least one IMiD and at least one anti-CD38 mAb or intolerant to a specific therapeutic drug class. Patients with primary refractory MM are eligible to participate as long as they meet the criteria of being triple class refractory. They may meet these criteria for triple class refractory MM if they have received at least one PI, at least one IMiD, and at least one Anti-CD38 mAb in their first line treatment or have had at least 2 prior lines of therapy.
Study Type Expanded Access
Expanded Access Type Intermediate-size Population, Treatment IND/Protocol
Intervention
  • Drug: Melphalan Flufenamide
    Melphalan flufenamide (melflufen) is an investigational peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells.
    Other Name: melflufen
  • Drug: Dexamethasone
    Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Paula O'Connor, MD 415-810-2784 op-110.medical.monitoring@oncopeptides.com
Contact: Debra Neubauer, RPh, MBA 410-591-2225 op-110.medical.monitoring@oncopeptides.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04534322
Responsible Party Oncopeptides AB
Study Sponsor Oncopeptides AB
Collaborators Not Provided
Investigators Not Provided
PRS Account Oncopeptides AB
Verification Date October 2020