Health Condition 1: null- Newly diagnosed multiple myeloma
Conditions
Interventions
Intervention1: Bortezomib: Dose:Intravenous bolus dose of 1.3 mg/m2
Dosage form: Lyophilizate for solution for intravenous administration of 3.5 mg.
Frequency: On 1, 4, 8 and 11th days of each cyc
Sponsors
RCI Syntez CJSC Russia
Eligibility
Inclusion criteria
Inclusion criteria: •male and female patients aged 18 and older •signed informed consent •patients with confirmed diagnosis of MM •satisfactory performance status (0-2 score on ECOG scale (Appendix 5) •PLT more than 75 000/mcl •Absolute neutrophil count more than 1000/mm3; •HB level more than 60 g/l •Creatinine clearance more than 30 ml/min •Consent of female patients (except for women with menopause more than 1 year (absence of menstruation for at least 12 months), nulliparity women) to use effective contraception (for example, oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, sterilization of the partner) •negative 3-hCG in serum or negative pregnancy test on urine •the consent of male patients to use contraception (use of their own, or ensure their usage by their partners) throughout the study •the ability of patients to appropriate cooperation in the research process
Exclusion criteria
Exclusion criteria: •A history of treatment with Bortezomib •Heavy, unstable or uncompensated somatic diseases •liver disease in the acute stage •gastric ulcer and duodenal ulcer •Coronary heart disease, uncompensated cardiovascular diseases like stenocardia, hypertension •HIV-infection •Severe organic renal irritation, diabetes, chronic arterial insufficiency, thyroid disease •Diseases of the central and peripheral nervous system, mental illness, including depressive disorders, seizures •Extensive surgery within two weeks prior to the study entry •Peripheral neuropathy more than second degree •Active systemic infection that requires treatment •A history of allergic reactions to products containing boron, mannitol or hydroxybenzoate •Male or female patients of childbearing age who refuse to use contraception during the study •Alcohol abuse •Drug addiction •Pregnancy and lactation •Participation in other clinical trials at the present time or within the last 3 months •Individual intolerance to the components included in the study drugs •Lack of cooperative attitude of the patient, refusal to carefully follow all instructions and prescriptions of the researcher according to the protocol •Clinically significant changes in laboratory parameters indicating undiagnosed disease and requiring further examination •Exacerbation of patientâ??s existing chronic disease that requires urgent action
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complete responses (CR) Timepoint: Day 1 of each cycle; final visit (day 105); as compared to Screening Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Assessment of adverse events and serious adverse events. b) Neurotoxicity questionnaire FACT/GOGTimepoint: After the administration of first dose of study drug until final visit.;a) Level of total response (ORR) b) Time to get a first response (TTR) Timepoint: Day 1 of each cycle; final visit (day 105); as compared to Screening Visit.;Evaluation of local tolerability at the injection site.Timepoint: On Day 1, 4, 8 and 11 of each chemotherapy cycle. | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed