Multiple Myeloma (Kahler’s disease)
Conditions
Interventions
Patients with multiple myeloma, meeting all eligibility criteria will be registered on entry and treated with 3 induction cycles with VCD, followed by Cyclophosphamide for stem cell mobilization and c
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS, i.e. at least one of the CRAB criteria should be present; 2. Measurable disease as defined by the presence of M-protein in serum or urine (serum Mprotein > 10 g/l or urine M-protein > 200 mg/24 hours), or abnormal free light chain ratio; 3. Age 18-65 years inclusive; 4. WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions); 5. Negative pregnancy test at inclusion if applicable; 6. Written informed consent. Inclusion for randomisation 1: 1. WHO performance 0-2; 2. Bilirubin and transaminases = 0.5 x 109/l and platelets > 20 x 10^9/l; 3. Patient is able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.
Exclusion criteria
Exclusion criteria: 1. Known intolerance of Boron; 2. Systemic AL amyloidosis; 3. Primary Plasmacell Leukemia; 4. Non-secretory MM; 5. Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control; 6. Severe cardiac dysfunction (NYHA classification II-IV, see appendix E); 7. Significant hepatic dysfunction, unless related to myeloma; 8. Patients with GFR <15 ml/min; 9. Patients known to be HIV-positive; 10. Patients with active, uncontrolled infections; 11. Patients with neuropathy, CTC grade 2 or higher; 12. 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; 13. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women); 14. Lactating women. Exclusion for randomisation 1: 1. Severe pulmonary, neurologic, or psychiatric disease; 2. CTCAE grade 3-4 polyneuropathy during Bortezomib treatment; 3. Allogeneic Stem Cell Transplantation (Allo SCT) planned; 4. Progressive disease. Exclusion for randomisation 2: 1. Progressive disease; 2. Neuropathy, except CTCAE grade 1; 3. CTCAE grade 3-4 polyneuropathy during Bortezomib treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first); 2. For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first; 3. For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment; 2. Overall survival measured from the time of registration /randomization R1/ randomization R2. Patients still alive or lost to follow up are censored at the date they were last known to be alive; 3. Toxicity. | — |
Contacts
Public ContactP. Sonneveld
P.O. Box 2040
Outcome results
None listed