NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS MedDRA version: 9.1 Level: HLT Classification code 10028229 Term: Multiple myelomas
Conditions
Interventions
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: DEL
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is 65 years of age or older at the time of signing the informed consent. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy. Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner?s vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy. Patient was a newly diagnosed multiple myeloma based on standard criteria Patient has measurable disease, defined as follows: - Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; - Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan). Patient has a Karnofsky performance status ≥ 50%. Patient has a life-expectancy >3 months. 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
Exclusion criteria
Exclusion criteria: Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days). Pregnant or lactating females Known positive for HIV or active infectious hepatitis type A, B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.;Secondary Objective: To determine progression free survival (PFS) To determine time to progression (TTP) To determine overall survival (OS) To determine whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients.;Primary end point(s): Primary: All patients will be included in the Intent-to-Treat (ITT) analysis. The safety points are: a grade 3 non-hematologic toxicity rate 70%) following the proposed RP-MPR therapy | — |
Countries
Italy
Outcome results
None listed