Multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Velcade
Product Name: Velcade
Pharmaceutical Form: Powder for injection
Trade Name: Revlimid
Product Name: Revlimid
Pharmaceutical Form: Tablet
Product Name: Dexamethasone
Pharmaceutical
Sponsors
Oslo University Hospital, Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1: • Patients must be >18 and 18 years Has completed first line treatment during Part 1 of this study (Norwegian sites) Has received 1.L treatment according to local guidelines (other sites) Must have measurable disease at diagnosis ECOG performance status score 0, 1 or 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 391 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Part 1: • Received more than one cycle of induction treatment for multiple myeloma. • Not able to comply with the study protocol • Any other prior or ongoing disease/health conditions incompatible with the study procedures • An active malignancy with lower expected survival than myeloma. Part 2: • An active malignancy with a lower life expectancy than myeloma • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. * Refractory to daratumumab and/or carfilzomib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: The primary objective of part 1 of the study is to determine how many patients achieve MRD negativity after induction, transplant and consolidation therapy. Part 2: 1. The primary objective 1 is to determine whether starting treatment at first sign of malignant plasma cells in the bone marrow measured by high sensitivity flow cytometry (2x10-6) (early treatment group) prolongs progression-free survival (PFS) compared with standard indication for relapse treatment according to IMWG guidelines. 2. The primary objective 2 is to investigate if there is a benefit of early relapse treatment vs. standard relapse treatment on OS. ;Secondary Objective: Part 1: 1. To determine PFS rate after Norwegian SOC (1.L) treatment. 2. To determine OS rate after Norwegian SOC first line (1.L) treatment. 3. To determine the overall response rate (ORR). 4. To determine the rate of sustained MRD-negativity. 5. To assess the toxicity of Norwegian SOC treatment, in a population based study. Part 2: 1. Time-to-next treatment (TTNT), Health-related quality of life (HRQOL), Rate of MRD negativity during 2.L treatment, and Safety. ;Primary end point(s): Primary Endpoint Part 1: 1. The number of patients who achieve MRD negativity measured by Euroflow at 30-45 days after consolidation therapy has ended. Primary Endpoints Part 2: 1. PFS 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. 2. OS rate of Arm A (MRD guided) vs Arm B defined as the time from randomization to death of any cause following 2.L treatment. ;Timepoint(s) of evaluation of this end point: Part 1: 30-45 days after the 4th cycle of consolidation has started. Part 2: See E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints Part 1: 1. The PFS rate of patients receiving 4 cycles of VRd as consolidation 2. The OS rate of patients receiving 4 cycles of VRd as consolidation 3. The number of AEs and relevant laboratory parameters monitored at every visit from entry into part 1 of the study until end of part 1 4. The proportion of patients who achieve PR or better following 4 cycles of VRd consolidation treatment Secondary Endpoints Part 2: To support claim of clinical benefit, the following secondary endpoints will be evaluated: 1. Time from randomization to start of 3.L therapy (TTNT) 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). 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. 4. The number of AEs and relevant laboratory parameters monitored at every visit (see SoA) from entry into part 2 of the study until end of study. ;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Lithuania, Norway
Contacts
Public ContactOslo Myeloma Center, Department of
Oslo Myeloma Center, Department of Hematology, Oslo University Hospital
Outcome results
None listed