DEXAMETHASONE for Multiple myeloma

Inclusion criteria

• {"criterion_text":"- Part 1: 1.\tPatient with newly diagnosed multiple myeloma (IMWG criteria) eligible for high-dose therapy and ASCT."}
• {"criterion_text":"- 2.\tPatient must be >18 and < 75 years of age at the time of signing the informed consent"}
• {"criterion_text":"- 3.\tMust have measurable disease as defined by the International Myeloma Working Group; serum monoclonal paraprotein (M-protein) level > 10 g/L or light chain multiple myeloma without measurable disease in the serum; serum immunoglobulin FLC > 100 mg/L and abnormal serum immunoglobulin kappa lambda FLC ratio."}
• {"criterion_text":"- 4.\tVoluntary written informed consent"}
• {"criterion_text":"- 5.\tEastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can be enrolled if caused by myeloma."}
• {"criterion_text":"- 6.\tPatient must be willing and able to adhere to the study protocol visit schedule and other protocol requirements."}
• {"criterion_text":"- 7.\tFemale of childbearing potential (FCBP) must have a confirmed negative serum pregnancy test within 10 to 14 days prior to inclusion."}
• {"criterion_text":"- 8.\tFCBP and male subject who are sexually active with FCBP must agree to use highly effective concomitant methods of contraceptive during the study and for at least 28 days following the last study drug dose. Male subjects must use contraception and refrain from donating sperm for at least 28 days after the last dose of lenalidomide according to Pregnancy Prevention Plan (Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information)."}
• {"criterion_text":"- Part 2: 1.\tPatient must be >CR and MRD negative measured by Euroflow NGF after 1.L therapy. The cutoff for inclusion into part 2 will be < 0.001% clonal plasma cells monitored in BM. Patients included directly into part 2 must have a MRD negative test which is less than one month old from time of testing after consolidation to screening for part 2."}
• {"criterion_text":"- 2.\tNorway: Has received 1.L treatment in part 1 of the study or has received ASCT as part of 1.L treatment outside the REMNANT study. Countries outside Norway: Has received 1.L treatment including ASCT according to local guidelines."}
• {"criterion_text":"- 3.\tECOG performance status score 0, 1 or 2"}
• {"criterion_text":"- 4.\tMust have measurable disease at diagnosis"}

Exclusion criteria

• {"criterion_text":"- Part 1: 1.\tReceived more than one cycle of induction treatment for multiple myeloma."}
• {"criterion_text":"- 2.\tPatient with ongoing or active systemic infection, active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positive"}
• {"criterion_text":"- 3.\tConcurrent medical or psychiatric condition or disease that is incompatible to HDM and ASCT or that will likely result in reduced study compliance and reduce ability to follow study procedures, or that in the opinion of the investigator, would constitute a hazard for participating in this study."}
• {"criterion_text":"- 4.\tAn active malignancy with a lower life expectancy than myeloma"}
• {"criterion_text":"- 5.\tFemale patient who has a positive serum pregnancy test during the screening period."}
• {"criterion_text":"- 6.\tFemale patient who is lactating during the screening period but are not willing to stop lactating prior to the first treatment cycle starts."}
• {"criterion_text":"- 7.\tKnown allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent."}
• {"criterion_text":"- Part 2: 1.\tAn active malignancy with a lower life expectancy than myeloma"}
• {"criterion_text":"- 2.\tKnown allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent."}
• {"criterion_text":"- 3.\tNot refractory to daratumumab and/or carfilzomib"}

Primary endpoints

• {"endpoint_text":"- Part 1: 1.\tThe number of patients who achieve MRD negativity measured by Euroflow at 30-45 days after the 4th cycle of consolidation therapy has started.","definition_or_measurement_approach":"MRD negativity measured by Euroflow at 30-45 days after the 4th cycle of consolidation therapy has started."}
• {"endpoint_text":"- Part 2: 1.\tPFS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to disease progression or death due to any cause following 2.L treatment.","definition_or_measurement_approach":"Progression-free survival (PFS) defined as time from randomization to disease progression or death due to any cause following 2.L treatment."}
• {"endpoint_text":"- Part 2: 2.\tOS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to death of any cause following 2.L treatment.","definition_or_measurement_approach":"Overall survival (OS) defined as time from randomization to death from any cause following 2.L treatment."}

Secondary endpoints

• {"endpoint_text":"- Part 1: 1.\tThe PFS rate of patients receiving 4 cycles of VRd as consolidation","definition_or_measurement_approach":"Progression-free survival rate following 4 cycles of VRd consolidation (definition not further specified in provided data)."}
• {"endpoint_text":"- Part 1: 2.\tThe OS rate of patients receiving 4 cycles of VRd as consolidation","definition_or_measurement_approach":"Overall survival rate following 4 cycles of VRd consolidation (definition not further specified in provided data)."}
• {"endpoint_text":"- Part 1: 3.\tThe number of AEs and relevant laboratory parameters monitored at every visit from entry into part 1 of the study until end of part 1","definition_or_measurement_approach":"Safety assessed by counting adverse events and monitoring relevant laboratory parameters at every visit during part 1."}
• {"endpoint_text":"- Part 1: 4.\tThe proportion of patients who achieve PR or better following 4 cycles of VRd consolidation treatment","definition_or_measurement_approach":"Objective response rate (proportion achieving PR or better) after 4 cycles of VRd consolidation."}
• {"endpoint_text":"- Part 2: 1.Time from randomization to start of 3.L therapy (TTNT)","definition_or_measurement_approach":"Time-to-next-treatment (TTNT) defined as time from randomization to start of third-line therapy."}
• {"endpoint_text":"- Part 2: 2.The proportion of patients who achieve MRD negativity during 2.L treatment, monitored by MRD Euroflow at 6 and 18 months in arm A, and after achieving CR in arm B (first MRD testing after 6 months).","definition_or_measurement_approach":"MRD negativity monitored by Euroflow at specified time points: at 6 and 18 months in arm A; in arm B after achieving CR (first MRD testing after 6 months)."}
• {"endpoint_text":"- Part 2: 3.Patient reported outcome HRQOL forms will be filled out by patients at defined time points during the study and finally at relapse after 2.L therapy.","definition_or_measurement_approach":"Health-related quality of life assessed by patient-reported outcome forms at defined time points and at relapse after 2.L therapy (specific instruments and schedule referenced in protocol documents)."}
• {"endpoint_text":"- Part 2: 4.The number of AEs","definition_or_measurement_approach":"Safety assessed by counting adverse events during part 2."}

Lithuania

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

30-04-2025

Processing Time Days

240

Number Of Sites

1

Number Of Participants

11

Norway

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

431

Number Of Sites

13

Number Of Participants

380

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway