None listed
Conditions
Interventions
Drug : Elanatumumab:C0D1 12 mg sc ,C0D4 32 mg sc,C0D8 76 mg sc then 76 mg sc weekly for cycles 1-6
For patients achieving a response of PR or better, 76 mg sc biweekly beginning on cycle 7
For patient
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject's age is 19 or older at the time of signing the informed consent form (ICF). 2. The subject must understand the ICF and voluntarily sign the ICF without having undergone any evaluation/procedure related to the trial. 3. The subject is willing and able to comply with the trial visit schedule and other protocol requirements. 4. Subjects with a diagnosis of MM and measurable disease defined by one or more of the following A. M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP) or B. M-protein = 200 mg/24 hours by 24-hour urine collection by urine protein electrophoresis (uPEP) or C. In subjects without measurable disease by sPEP or uPEP: the concentration of the involved light chain in serum free light chain (sFLC) exceeds 100 mg/L (10 mg/dL) and the kappa/lambda FLC ratio is abnormal. * Patients with measurable disease and extramedullary disease are eligible for enrolment if they have measurable extramedullary lesions. Such subjects require a PET-CT follow-up for response evaluation. Patients with extramedullary disease (EMD) alone are not allowed to participate. In other words, patients with the only measurable disease being plasmacytoma are not allowed to participate. For the definition of EMD, see Section 8.1.3. 5. The subject must have received at least two prior anti-myeloma treatments. (Note: Multiple agents in one cycle are allowed [e.g. induction therapy, autologous stem cell transplant (with or without), consolidation therapy (with or without) and/or maintenance therapy]. 6. Subjects must have received at least one dose of a proteasome inhibitor and lenalidomide. 7. The subject must have achieved a minimal response (MR) or better on at least one prior anti-myeloma therapy. 8. The subject must have documented disease progression during or after the last anti-myeloma treatment. 9. The subject's Eastern Cooperative Oncology Group (ECOG) performance status score is 0, 1, or 2. 10. Female of childbearing potential (FCBP) must be A. Two negative pregnancy tests prior to the start of trial treatment, verified by the investigator. Women of childbearing potential must agree to pregnancy tests performed during the course of the trial and after the end of trial treatment, in parallel with the trial. The investigator must verify the results of the two negative pregnancy tests performed before the start of trial treatment. This also applies if the subject is practising true abstinence* from sexual contact with members of the opposite sex. B. Commit to true abstinence* from sexual contact with members of the opposite sex (which must be reviewed monthly and documented in the source document) and agree to use and be able to comply with two forms of contraception as follows: One highly effective method of contraception and one additional effective method of contraception (barrier) that is effective without interruption for 28 days prior to the start of trial treatment, during the trial treatment period (including the period of dose interruption), and for at least 150 days after the last dose of megestrol, and that the subject is able to comply with (including during dose interruptions). Note: Commit to true abstinence* from sexual contact with members of the opposite sex (which must be reviewed monthly and documented in the patient's chart) or be able to agree to and adhere to the use of two forms of contraception as follows: One highly effective method of contraception and one additional effective (barrier) method of contr
Exclusion criteria
Exclusion criteria: 1 The test subject has a history of having received treatment with megestrol in the past. 2 Subjects who have previously been treated with anti-BCMA agents (including CAR T cell therapy, bispecific and antibodies). 3 Subjects who have received investigational drug within 28 days or 5 half-lives (whichever is shorter) of starting treatment in the trial. A. Participation in other interventional clinical trials at the same time as this clinical trial is not permitted, except for those who have completed treatment with the previous investigational drug and are currently undergoing long-term follow-up. 4 The subject has received any of the following. A. Plasmapheresis performed within 28 days prior to the start of the trial treatment B. Major surgery (as defined by the investigator) performed within 28 days of the start of the trial treatment C. Radiotherapy other than local palliative therapy for bone lesions associated with myeloma performed within 14 days of the start of the trial treatment D. Systemic antimyeloma drug therapy of any type used within 14 days of the start of the trial treatment E. Use of a potassium-competitive acid blocker (e.g., tegoprazole, vonoprazole) within 7 days of the start of the first dose. 5. Have received an allogeneic stem cell transplant within 1 year or an autologous stem cell transplant within 12 weeks prior to first dose. Patients who have received an allogeneic stem cell transplant must be free of evidence of active graft-versus-host disease (GVHD). 6 The subject has a plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant light chain amyloidosis. 7 The subject has a central nervous system (CNS) involvement of myeloma. central nervous system (CNS) involvement of myeloma is known to the subject. 8 The subject has any significant medical condition, including active or uncontrolled infection or abnormal laboratory values, or psychiatric illness, that places the subject at unacceptable risk from treatment-related complications if the subject participates in the trial. 9 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: 7 days for mild or asymptomatic infection, or 14 days for severe/serious illness, or a longer period may be required at the investigator's clinical discretion, prior to the start of trial treatment. i) Acute symptoms have resolved and there is no high risk associated with it during the study participation. . No need for tracking and repeated testing for COVID-19. 10. The subject has a disease that may confuse the interpretation of the study data. 11 The subject has any of the following abnormal laboratory test results: A. Absolute neutrophil count (ANC) < 1,000/µL. GCSF administration within 7 days (14 days for pegfilgrastim) prior to the screening complete blood count (CBC) test to achieve the minimum ANC level is not permitted. B. Platelet count: Platelet count of < 75,000/µL for subjects with < 50% of bone marrow nucleated cells being plasma cells, and platelet count of < 50,000/µL for subjects with = 50% of bone marrow nucleated cells being plasma cells (no transfusions allowed within 7 days prior to screening CBC)* C. Hemoglobin < 8 g/dL (< 4.9 mmol/L)* * * Subjects who do not meet the criteria for hematological function due to MM-related cytopenia (e.g., due to extensive bone marrow involvement by MM) may receive transfusions and be re-exami
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival period | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungil Koh
Seoul National University Hospital
Outcome results
None listed