Multiple myeloma MedDRA version: 15.0 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Kuopio University Hospital, Clinic of Internal Medicine/Center of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 - 70 years - Written informed consent - Patients with a symptomatic, previously untreated, ISS 1-3 multiple myeloma - Measurable disease: serum paraprotein > 10g/l or urine paraprotein > 200mg/24 hours or abnormal free light chain ratio - WHO performance status 0-3 (if WHO 3, must be related to myeloma, not due to comor-bidities) - Eligible for ASCT - Sufficient renal function, glomerular filtration rate (GFR) assessed by Modification of Diet in Renal Disease formula (MDRD) > 15 ml/min unless on hemodialysis - Women of childbearing potential (WCBP) must have a negative serum or urine preg-nancy test prior to starting lenalidomide. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive methods; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasecomized partner) while on lenalidomide. WCBP must agree to have pregnancy tests every 4 weeks while on lenalidomide. - Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on lenalidomide, when temporarily stopping lenalidomide and 28 days after the last dose of lenalidomide. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous chemotherapy or radiotherapy except local radiotherapy (10-20 Gy) or corticos-teroids maximum dexamethasone 160 mg in two weeks before study inclusion for symptom control - Peripheral neuropathy grade = 2 - Contraindication to use of thromboembolic prophylaxis - Significant hepatic dysfunction (serum bilirubin 3 x >ULN, transaminases = 2,5 x upper limit), unless related to myeloma - Severe cardiac dysfunction - Severe renal failure, GFR < 15ml/min, if not in hemodialysis - Other serious medical or psychiatric illness - Uncontrolled infection - Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma - Pregnancy - Lactating women - HIV-positive patients, HBsAg or HCV positive patients - Primary plasma cell leukemia - Systemic AL amyloidosis or myeloma associated amyloidosis if not eligible for ASCT - Allogeneic stem cell transplantation planned - Participants receiving any other investigational agents - Participants with known brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study is to determinate the rate of immunophenotypic remission after induction treatment with Revlimid Velcade Dexamethasone (RVD) prior to high-dose melphalan and autologous stem cell transplantation (HDT-ASCT), after HDT-ASCT, and during lenalidomide maintenance in patients with multiple myeloma.;Secondary Objective: Not applicable;Primary end point(s): 1) Complete response rate (including nCR/CR rate, immunophenotypic remission of nCR/CR patients and molecular remission of patients in immunophenotypic remis-sion/stringent CR) after induction treatment (3 cycles) and 3-4 months after ASCT 2) Improvement of responses during lenalidomide maintenance 3) Progression-free survival after study inclusion (comparison to VelDex-study) ;Timepoint(s) of evaluation of this end point: - At entry: before start of induction ( skeleton x-ray and cytogenetic tests in 3 months before start and laboratory and bone marrow in 2 weeks before start) - After 2 RVD - After 3 RVD - After mobilization/At ASCT - After ASCT: 2-3 months after ASCT - During maintenance first year: with 3 months interval - Second year: with 4 months interval | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Feasibility of subcutaneous use of bortezomib as a part of induction therapy in myeloma patients 2) Feasibility of three-drug combination induction therapy (discontinuation of therapy, de-crease of doses) 3) nCR/CR rate after 2 cycles, at mobilization; 3 months, 6 months, 9, 12, 16, 20, 24 months after ASCT 4) Overall response rate 5) Number of CD34+ cells collected after low-dose CY + G-CSF vs. G-CSF alone-mobilization, number of aphereses and costs according to the mobilization arm, graft composition 6) Duration of treatment 7) Overall survival from the study inclusion ;Timepoint(s) of evaluation of this end point: After 2 cycles, at mobilization; 3 months, 6 months, 9, 12, 16, 20, 24 months after ASCT | — |
Countries
Finland
Contacts
Public ContactRaija Silvennoinen
Kuopio University Hospital
Outcome results
None listed