Health Condition 1: null- Multiple Myeloma
Conditions
Interventions
Intervention1: P276-00: P276-00 injection to be administered daily from day 1 to day 5 per 21 day cycle in 200 ml of 5% dextrose as an intravenous infusion over 30 minutes for total of six cycles or t
Sponsors
Piramal Life Science
Eligibility
Inclusion criteria
Inclusion criteria: Subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy Monoclonal protein in the serum of greater than or equal to 1 g/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200 mg/ 24 hours, or measurable light chains by free light chain assay of greater than or equal to 10 mg/dL, or measurable plasmacytoma Age greater than or equal to18 years ECOG performance status less than or equal to 2 Life expectancygreater than or equal to 3 months Hemoglobin greater than or equal to8.0 gm/dL Absolute Neutrophil Count (ANC) greater than or equal to1000 cells/mm3 Platelets countgreater than or equal to 50,000/mm3 SGOT/AST less than 3.0 x institutional upper limits of normal Serum SGPT/ALT less than 3.0 x institutional upper limits of normal Serum creatinine less than 2.5mg/dL Serum total bilirubin less than 1.5 x institutional upper limits of normal Woman of childbearing potential with a negative serum pregnancy test. In addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: Subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like G-CSF in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade less than or equal to 1) from adverse effects of such therapy received prior to 4 weeks Subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks. History of allergic reactions attributed to compounds of similar chemical composition to P276-00. Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months. Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years. Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, cardiac ejection fraction 40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or nursing Subjects known to be seropositive for the human immunodeficiency virus or any history or evidence from physical examination of HIV infection. Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of maximaum tolerated dose of P276-00 Characterization of dose limiting and other toxicities of P276-00 Timepoint: end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine pharmacokinetics of P276-00 To evaluate clinical response of P276-00 To perform exploratory analysis of serum and molecular markers associated with use of and/or response to P276-00 in MM Timepoint: end of the study | — |
Countries
India
Contacts
Public ContactDr Sanjeev C Hegde
Outcome results
None listed