Multiple Myeloma
Conditions
Interventions
The patients receive nine courses MPV treatment (= Melphalan, Prednisone, Bortezomib). (Bortezomib is the generic name Velcade). Each course lasts five weeks. The total duration of the treatment is 11
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC, Clinical Trial Center
Postbus 2040
3000 CA Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: - Previously untreated patients with a confirmed diagnosis of symptomatic multiple myelomaaccording to IMWG criteria (see appendix A) - Age = 75 years - WHO performance status 0-3, WHO 4 performance status is allowed when related to MM (see appendix E) - Measurable disease as defined by the presence of M-protein in serum or urine and/or abnormal free light chain (FLC) ratio with involved FLC (see appendix A for definitions). (If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation). - Patient gives consent for extra bone marrow, blood and skin biopsy sampling - Written informed consent
Exclusion criteria
Exclusion criteria: - Non-secretory MM - Systemic Amyloid Light-chain (AL) amyloidosis - Polyneuropathy, grade 1 with pain or grade = 2 - Severe cardiac dysfunction (NYHA classification IV, appendix F) - Severe pulmonary dysfunction defined as breathlessness at rest - Significant hepatic dysfunction (total bilirubin = 30 ¦Ìmol/l or transaminases = 3 times normal level), unless related to MM - Renal insufficiency requiring dialysis - Patients with active, uncontrolled infections - Pre-treatment with cytostatic drug, immunomodulatory drugs (IMiDs) or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed - Patients known to be Human Immunodeficiency Virus (HIV)-positive - Active malignancy other than MM requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity - Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule - Patients with plasma cell leukemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint for this trial is the discontinuation rate, i.e. the proportion of patients who cannot complete all 9 MPV cycles according to protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC), version 4.0 Overall response rate where response is defined as sCR, CR, VGPR or PR Time to response Progression free survival , defined as time from registration to progression, relapse or death from any cause whichever occurs first Overall survival, measured from time of registration to death. Patients still alive or lost to follow up are censored at the date they were last known to be alive (date last contact) Relative dose intensity and cumulative dose intensity of Melphalan, Prednisone and Bortezomib Predictive value of geriatric assessments Quality of life as defined by the EORTC QLQ-C30 and MY-20 definitions Association of biomarkers for biological age with toxicity and feasibility of the treatment Associations with toxicity and with feasibility of the treatment regimen of polymorphism of genes involved in drug metabolism and related with bortezomib-induced PNP Association of risk factors and myeloma gene expression profiles with prognosis The incidence of bone remodeling during treatment and the association with response to therapy Cost effectiveness as defined by the EQ-5D-5L and the involved costs | — |
Contacts
Public ContactS. Zweegman
VUMC Afd. Hematologie; Postbus 7057; 1007 MB Amsterdam
Outcome results
None listed