Multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Velcade (bortezomib)
Product Name: Velcade
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
CAS Number: 179324-69-7
Current Sponsor code: OMC02/20
Con
Sponsors
Oslo University Hospital, Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be > 18 years of age at the time of signing the informed consent. 2.Newly diagnosed multiple myeloma (International Myeloma Working Group (IMWG) criteria) in-eligible for high-dose therapy and ASCT. 3. Measurable disease as defined by the IMWG: a)Serum monoclonal paraprotein (M-protein) level > g/L or urine M-protein level > 200 mg/24 hours; or b) Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC > 100 mg/L and abnormal serum immunoglobulin kappa lambda FLC ratio. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. ECOG 3 can be enrolled if caused by myeloma. 5. Clinical laboratory values meeting the following criteria during the Screening Phase. a)Adequate bone marrow function: - Hemoglobin > 7,5 g/dL (transfusion is permitted, recombinant human EPO use is permitted, however transfusion is not permitted within 3 days before screening). - Absolute neutrophil count > 1.0 x 109/L (G-CSF use is permitted). -Platelet count > 70 x 109/L. b. Adequate renal function: - eGFR > =30 ml/min/m2 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. Prior or current systemic therapi for multiple myeloma with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) of corticosteroids before treatment. 2. Radiation therapy for treat,ent of plasmacytoma within 14 days of treatment (local radiation for pain control or to prevent fracture is allowed within 14 days of treatment). 3. Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positivity. 4. Any pther serious medical or psychiatric illness that could, in the investigator´s opinion, potentially interfere with the completion of treatment according to protocol. 5. No active malignancy with a lower life expectancy than myeloma. 6. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 7.Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine how many patients achieve minimal residual disease (MRD) negativity during and/or after 2 cycles of IVRd, followed by 6 cycles of IVR and 10 cycles of IR.;Secondary Objective: 1.To assess the overall response rate (ORR) after 2 cycles og IVRd followed by 6 cycles of IVR and 10 cycles of IR. 2.To determine the progression free survival (PFS) rate after 2 cycles of IVRd followed by 6 cycles of IVR. 10 cycles of IR and continuous R. 3. To determine the overall survival (OS) rate after 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R. 4. To evaluate health related quality of life (HRQL) and symptoms of steroid toxicity during IVRd (cycle 1 and 2 with dexamethasone) compared to IVR (cycle 3 and 4 without dexamethasone) treatment.;Primary end point(s): The proportion of patients who achieve MRD negativity measured NGF Euroflow during and/or after 18 cycles of study treatment.;Timepoint(s) of evaluation of this end point: Approximately 36 months after FPI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of patients who achieve partiel response (PR) or better following 18 cycles of study treatment. 2. The PFS rate of receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R. 3. The OS rate of patients receiving 2 cycles of IVRd followed by 6 cycles of IVR, 10 cycles of IR and continuous R. 4. The change inHRQL trajectories and steroid toxicity (day 22 - dag 1) during IVRd (cycle 1 and 2) compared to IVR (cycle 4 and 5).;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Denmark, Norway, Sweden
Contacts
Public ContactOslo Myeloma Center
Oslo Myeloma Center, Department of Hematology, Oslo University Hospital
Outcome results
None listed