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

Phase 1

• Conditions: ewly diagnosed symptomatic Multiple Myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000320-33-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-25
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

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 or proven plasmacytoma by biopsy (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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 240

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, imunnomodulatory 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified