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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment
Relapsed and/or Refractory Multiple Myeloma Drug: Melphalan Flufenamide Drug: Dexamethasone

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.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: An Expanded Access Program Protocol for Melphalan Flufenamide in Combination With Dexamethasone in Patients With Triple Class Refractory Multiple Myeloma



Intervention Details:
  • 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. A clinically confirmed prior diagnosis of multiple myeloma with documented disease progression.
  2. Triple-class refractory multiple myeloma (TCR MM). Triple-class refractory defined as refractory to at least one PI, at least one IMiD, and at least one Anti-CD38 mAb. Patients (with non-primary refractory MM) are required to have a minimum of at least 2 prior lines of therapy.

    Patients with primary refractory MM are eligible if they meet the criteria for TCR MM. They may meet these criteria for TCR 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.

  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  4. Adequate organ function with the following laboratory results during screening (within 21 days) and immediately before treatment administration on Cycle1 Day1:

    • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
    • Platelet count ≥ 75,000 cells/mm3 (75 x 109/L)
    • Hemoglobin ≥ 8.0 g /dL (Red blood cell (RBC) transfusions are permitted)
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), except patients diagnosed with Gilbert's syndrome AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
    • Renal function: Estimated glomerular filtration rate (eGFR) by CKD-EPI formula of ≥ 45 mL/min.
  5. Has not been enrolled in another melflufen clinical study and is not eligible for or does not have access to enroll in another ongoing clinical study of melflufen;
  6. Contraception:

    1. Male patients: Agree to use contraception during the treatment period and for at least 3 months after the last dose of treatment and refrain from donating sperm during this period.
    2. Female patients: Eligible to participate if not pregnant or not breastfeeding, and at least one of the following conditions applies:

      • Not a woman of childbearing potential (WOCBP) or
      • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of treatment.

Exclusion Criteria:

  1. Known platelet transfusion refractory (i.e. platelet count fails to increase by > 10,000 cells/mm3 after a transfusion of an appropriate dose of platelets);
  2. Other malignancy diagnosed or requiring treatment within the past 3 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, and very low and low risk prostate cancer patients in active surveillance.
  3. Concurrent known or suspected (symptomatic) amyloidosis or plasma cell leukemia.
  4. Any of the following treatments, within the specified timeframe:

    • Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy.
    • IMiDs, PIs and or corticosteroids within 2 weeks prior to initiation of therapy.
    • Other investigational therapies within 4 weeks of initiation of therapy.
    • Prednisone up to but no more than 10 mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy.
  5. Prior stem cell transplant (autologous and/or allogeneic) within 6 months of initiation of therapy.
  6. Prior allogeneic stem cell transplant with active graft-versus-host- disease (GVHD);
  7. Prior major surgical procedure or radiation therapy within 4 weeks of the first dose of treatment (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy);
  8. Prior treatment with melflufen

Key eligibility criteria listed and is not all inclusive


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534322


Contacts
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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

Locations
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United States, Arkansas
Highlands Oncology Group Available
Springdale, Arkansas, United States, 72762
Contact: Research    479-872-8130      
Contact    479-587-1700      
United States, Illinois
University of Illinois Cancer Center Available
Chicago, Illinois, United States, 60612
Contact: Meredith Russell    312-355-5112    cancertrials@uic.edu   
United States, Ohio
Gabrail Cancer Center Available
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-492-3345 ext 208    csmith@gabrailcancercenter.com   
United States, Utah
Community Cancer Trials of Utah Available
Ogden, Utah, United States, 84405
Contact    801-689-3909    admin@communitycancertrials.com   
United States, Washington
Northwest Medical Specialties Available
Tacoma, Washington, United States, 98405
Contact: Stephanie Parker    253-306-0532    sparker@southsoundcare.org   
Sponsors and Collaborators
Oncopeptides AB
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Responsible Party: Oncopeptides AB
ClinicalTrials.gov Identifier: NCT04534322    
Other Study ID Numbers: OP-110
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Melphalan
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action