Main info

Identificatie:

HO123 MM

Sponsor:

HOVON

Working group party:

Myeloma

Age:

>= 75

Stadium:

1st lijn

Echelon:

Level D

Included patients:

240

(of 240)

Active sites:

67

(of 64)

Title:

Feasibility and Efficacy of dose adjusted Melphalan – Prednisone – Bortezomib (MPV) in elderly patients ≥ 75 years of age with newly diagnosed Multiple Myeloma; a non-randomised phase II study

Timeline

News

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Not any more

Objectives:

Primary objective

• To assess the feasibility, defined as the discontinuation rate, of a dose-adapted MPV scheme in MM patients ≥ 75 years of age

Secondary objectives

• To assess toxicity
• To assess efficacy, defined as response rate, PFS and OS
• To assess time to response
• To assess the relative dose intensity of MPV
• To assess the cumulative dose intensity of MPV
• To assess the predictive value of geriatric assessments, biomarkers reflecting biological age and sarcopenia with respect to discontinuation rate, toxicity and efficacy
• To assess Quality of Life
• To analyze the value of polymorphism of genes involved in drug metabolism in predicting bortezomib-induced PNP
• To assess the prognostic value of risk factors at diagnosis, including β2-microglobulin and chromosomal abnormalities
• To analyze the prognostic value of myeloma gene expression profiles
• Cost effectiveness analysis

Eligibility

Inclusion Criteria:

• Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according 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:

• 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 μmol/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

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals