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


- candidate number15639
- NTR NumberNTR4244
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2013
- Secondary IDs2013-000320-33  EudraCT nummer
- Public TitleFeasibility and Efficacy of dose adjusted Melphalan 每 Prednisone 每 Bortezomib (MPV) in elderly patients >= 75 years of age with newly diagnosed Multiple Myeloma; a non-randomised phase II study
- Scientific TitleFeasibility and Efficacy of dose adjusted Melphalan 每 Prednisone 每 Bortezomib (MPV) in elderly patients >= 75 years of age with newly diagnosed Multiple Myeloma; a non-randomised phase II study
- ACRONYMHOVON 123 MM
- hypothesisThis study aims to assess the feasibility of a dose-adjusted MPV scheme in patients >= 75 years of age and to assess the value of geriatric assessments to predict both feasibility and efficacy.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma, Elderly patients, Bortezomib
- Inclusion criteriaPreviously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria Age >= 75 years; WHO performance status 0-3 for patients, WHO performance status is allowed when related to MM 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
Written informed consent
- Exclusion criteriaNon-secretory MM
Systemic AL amyloidosis
Polyneuropathy grade 1 with pain or grade >= 2
Severe cardiac dysfunction (NYHA classification IV)
Severe pulmonary dysfunction defined as breathlessness at rest Significant hepatic dysfunction (total bilirubin >= 30 足mol/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, 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 HIV-positive
Active malignancy 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2013
- planned closingdate1-nov-2021
- Target number of participants240
- InterventionsThe 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 months (9 cycles of 4 weeks), then at follow up to 5 years. Progression or severe toxicity, treatment stops and the patient in follow-up. The first visit takes ~ 2 hours, then it takes ~ 1 hour hospital visit. Response term evaluation after treatment, there is 1, 3, 5, 7 and 9.
The study of blood and bone marrow decreased but this is done during regular withdrawals so that the patient is not pricked extra. Additionally in this study are five quality of life questionnaires completed at various times. A geriatric assessment is also taken that extra time consuming and can be for the patient. Incriminating Finally, a huisbiopt decreased.
- Primary outcomeThe 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 outcomeSafety 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
- TimepointsAt entry: before start of treatment During induction therapy after 1, 3, 5 ,7 and 9 cycles
- Trial web sitewww.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. Dr. S. Zweegman
- CONTACT for SCIENTIFIC QUERIESMw. Dr. S. Zweegman
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
HOVON, KWF Kankerbestrijding, Janssen Pharmaceutica
- PublicationsN/A
- Brief summaryStudy phase: phase II
Study design: Prospective, multicenter Duration of treatment: 9 months
Study objective: To assess discontinuation rate, i.e. the proportion of patients who cannot complete all 9 MPV cycles according to protocol
To assess relative dose intensity and cumulative dose intensity of MP- Bortezomib
To assess predictive value of geriatric assessments and the patients quality of life
- Main changes (audit trail)15-jan-2016: EB

Amendement change inclusion and exclusion:
Inclusion criteria new:
♦ 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 new:
♦ 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 米mol/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
- RECORD29-okt-2013 - 15-jan-2016


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