Clinical Trials Logo

Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT04534322
Other study ID # OP-110
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date March 2021
Source Oncopeptides AB
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

To provide early treatment access and evaluate the safety of melflufen and dexamethasone in patients with triple class refractory (TCR) multiple myeloma (MM).


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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States Gabrail Cancer Center Canton Ohio
United States University of Illinois Cancer Center Chicago Illinois
United States Beacon Cancer Care Coeur d'Alene Idaho
United States Texas Oncology Dallas Texas
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Prisma Health Cancer Institute Greenville South Carolina
United States Weill Cornell Medicine - Multiple Myeloma Center New York New York
United States Community Cancer Trials of Utah Ogden Utah
United States Oregon Health & Science University Portland Oregon
United States Highlands Oncology Group Springdale Arkansas
United States Northwest Medical Specialties Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
Oncopeptides AB

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT03140943 - Carfilzomib Thalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Phase 2
Recruiting NCT05066022 - A Study to Access the Safety and Efficacy of CT0590 in Patients With Relapsed and/or Refractory Multiple Myeloma N/A
Recruiting NCT06182696 - OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM Phase 1/Phase 2
Recruiting NCT03715478 - Multi-Center Study of GSK2857916 in Combination With Pomalidomide and Dex Phase 1/Phase 2
Completed NCT02917941 - A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma Phase 2
Not yet recruiting NCT03903406 - Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot Study
Completed NCT03242460 - The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Phase 2
Terminated NCT03836053 - Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma Phase 1
Recruiting NCT05719701 - Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma Phase 1/Phase 2
Recruiting NCT05297240 - Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.
Terminated NCT04272775 - A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) Phase 1
Not yet recruiting NCT06351644 - ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Phase 1/Phase 2
Withdrawn NCT04392648 - A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Phase 1
Active, not recruiting NCT01632150 - Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma Phase 2
Completed NCT02831686 - A Study to Test the Combination of Selinexor (KPT-330), Ixazomib, and Dexamethasone in Patients With Myeloma Phase 1
Recruiting NCT06153251 - A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma Phase 1
Completed NCT00882063 - Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Refractory Multiple Myeloma Phase 1/Phase 2
Terminated NCT04017130 - A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT03416374 - A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy Phase 4
Recruiting NCT05486975 - This is an Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Treatment With CT0591CP in Patients With Relapsed and/or Refractory Multiple Myeloma. Early Phase 1