Patients with Multiple Myeloma
Conditions
Interventions
Trade Name: VELCADE
Product Name: VELCADE
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Current Sponsor code: VELC
Sponsors
DUTCH BELGIAN COOPERATIVE GROUP FOR HEMATOLOGY ONCOLOGY - HOVON
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is of a legally consenting age as defined by local regulations. 2. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements. 3. 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 4. 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 therapy. 5. 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 bortezomib therapy. 6. Patient was previously diagnosed with multiple myeloma based on standard criteria. 7. Patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease. 8. Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease. 9. Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib. 10. Before the salvage treatment with bortezomib-based regimens, patient must have 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) or abnormal free light chain ratio 11. Patient has a Karnofsky performance status =60%. 12.Patient has not: - other malignancy within the past 3 years. Exceptions: basal cell or non metastatic squamous; cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 carcinoma of the cervix. - used any investigational drugs within 30 days before randomization. - uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis which prevent the use of study drug. - uncontrolled diabetes which prevent the use of high-dose Dexamethasone. - peripheral neuropathy > grade 2 as per NCI-CTC version 4.0 which prevents the use of bortezomib. - history of allergic reaction attributable to compounds containing boron or mannitol. - concurrent medical condition or disease (e.g., active systemic infection, pulmonary disease) that is likely to in
Exclusion criteria
Exclusion criteria: 1.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. 2.Pregnant or lactating females 3.Known positive for HIV or active infectious hepatitis type A, B or C 4.Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0 5.Infiltrative pulmonary disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of a prolonged treatment with bortezomib twice monthly s.c. in association with dexamethasone, after a salvage treatment containing bortezomib i.v. in relapsed and refractory multiple myeloma patients. - To assess the safety of prolonged treatment with bortezomib s.c.;Secondary Objective: - To assess the prognostic value of risk factors (International Staging System [ISS] stage, FISH, age).;Primary end point(s): - To determine time to progression (TTP);Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine - Overall survival (OS) - Progression free survival (PFS) - Objective overall response rate (ORR) - Duration of response - Time to response - Time to the next anti-myeloma therapy (TTNT) - TTP measured from the beginning of the salvage treatment - Role of the type of salvage treatment - Role of previous treatments - Incidence of grade 3 and 4 hematological and non-hematological adverse events (AEs) - Exploratory assessment on prognosis (ISS, age and FISH abnormalities).;Timepoint(s) of evaluation of this end point: 60 months | — |
Countries
Italy, Netherlands
Contacts
Public ContactDENNIS STINENBOSCH
DUTCH BELGIAN COOPERATIVE GROUP FOR HEMATOLOGY ONCOLOGY - HOVON
Outcome results
None listed