Studies
| Study First Submitted Date | 2020-08-26 |
| Study First Posted Date | 2020-09-01 |
| Last Update Posted Date | 2021-03-18 |
| Verification Month Year | March 2021 |
| Verification Date | 2021-03-31 |
| Last Update Posted Date | 2021-03-18 |
Detailed Descriptions
| Sequence: | 20643330 |
| 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. |
Facilities
| Sequence: | 199230162 | Sequence: | 199230163 | Sequence: | 199230164 | Sequence: | 199230165 | Sequence: | 199230166 | Sequence: | 199230167 | Sequence: | 199230168 | Sequence: | 199230169 | Sequence: | 199230170 | Sequence: | 199230171 | Sequence: | 199230172 |
| Name | Highlands Oncology Group | Name | Beacon Cancer Care | Name | University of Illinois Cancer Center | Name | Weill Cornell Medicine – Multiple Myeloma Center | Name | Gabrail Cancer Center | Name | Oregon Health & Science University | Name | Prisma Health Cancer Institute | Name | Texas Oncology | Name | Community Cancer Trials of Utah | Name | Virginia Cancer Specialists, PC | Name | Northwest Medical Specialties |
| City | Springdale | City | Coeur d’Alene | City | Chicago | City | New York | City | Canton | City | Portland | City | Greenville | City | Dallas | City | Ogden | City | Fairfax | City | Tacoma |
| State | Arkansas | State | Idaho | State | Illinois | State | New York | State | Ohio | State | Oregon | State | South Carolina | State | Texas | State | Utah | State | Virginia | State | Washington |
| Zip | 72762 | Zip | 83814 | Zip | 60612 | Zip | 10065 | Zip | 44718 | Zip | 97239 | Zip | 29605 | Zip | 75230 | Zip | 84405 | Zip | 22031 | Zip | 98405 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
| Sequence: | 95661313 | Sequence: | 95661315 | Sequence: | 95661316 | Sequence: | 95661317 | Sequence: | 95661318 | Sequence: | 95661319 | Sequence: | 95661320 | Sequence: | 95661321 | Sequence: | 95661322 | Sequence: | 95661323 | Sequence: | 95661324 | Sequence: | 95661325 | Sequence: | 95661326 | Sequence: | 95661327 | Sequence: | 95661328 | Sequence: | 95661329 | Sequence: | 95661330 | Sequence: | 95661331 | Sequence: | 95661314 |
| Mesh Term | Dexamethasone | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antiemetics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Gastrointestinal Agents | Mesh Term | Glucocorticoids | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Antineoplastic Agents, Hormonal | Mesh Term | Antineoplastic Agents | Mesh Term | Antineoplastic Agents, Alkylating | Mesh Term | Alkylating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Myeloablative Agonists | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Melphalan |
| Downcase Mesh Term | dexamethasone | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antiemetics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | glucocorticoids | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | antineoplastic agents, hormonal | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | antineoplastic agents, alkylating | Downcase Mesh Term | alkylating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | myeloablative agonists | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | melphalan |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Conditions
| Sequence: | 51967964 |
| Name | Relapsed and/or Refractory Multiple Myeloma |
| Downcase Name | relapsed and/or refractory multiple myeloma |
Id Information
| Sequence: | 40000517 |
| Id Source | org_study_id |
| Id Value | OP-110 |
Countries
| Sequence: | 42391433 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52279706 | Sequence: | 52279707 |
| Intervention Type | Drug | Intervention Type | Drug |
| Name | Melphalan Flufenamide | Name | Dexamethasone |
| Description | Melphalan flufenamide (melflufen) is an investigational peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. | Description | 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. |
Browse Conditions
| Sequence: | 192681959 | Sequence: | 192681960 | Sequence: | 192681961 | Sequence: | 192681962 | Sequence: | 192681963 | Sequence: | 192681964 | Sequence: | 192681965 | Sequence: | 192681966 | Sequence: | 192681967 | Sequence: | 192681968 | Sequence: | 192681969 | Sequence: | 192681970 | Sequence: | 192681971 | Sequence: | 192681972 |
| Mesh Term | Multiple Myeloma | Mesh Term | Neoplasms, Plasma Cell | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Hemostatic Disorders | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Paraproteinemias | Mesh Term | Blood Protein Disorders | Mesh Term | Hematologic Diseases | Mesh Term | Hemorrhagic Disorders | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases |
| Downcase Mesh Term | multiple myeloma | Downcase Mesh Term | neoplasms, plasma cell | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | hemostatic disorders | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | paraproteinemias | Downcase Mesh Term | blood protein disorders | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | hemorrhagic disorders | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48128931 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Oncopeptides AB |
Eligibilities
| Sequence: | 30645922 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: A clinically confirmed prior diagnosis of multiple myeloma with documented disease progression. 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. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 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. 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; Contraception: 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. 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: 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); 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. Concurrent known or suspected (symptomatic) amyloidosis or plasma cell leukemia. 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. 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 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); Prior treatment with melflufen Key eligibility criteria listed and is not all inclusive |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254228554 |
| Number Of Facilities | 11 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26565044 |
| Intervention Id | 52279706 |
| Name | melflufen |
Responsible Parties
| Sequence: | 28759288 |
| Responsible Party Type | Sponsor |