The purpose of this study is to determine safety of P276-00 in patients with advanced multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of multiple myeloma.
This is an open label multicenter study of P276-00 in subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma. Cohort of 3 subjects will be enrolled at starting dose of P276-00 which is 50 mg/m2/day to be given intravenously from day 1 to day 5 every 21 days. This 21 day administration constitutes one cycle of P276-00. Six such cycles will be administered to the subjects. If the dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00 till maximum tolerated dose is determined. Safety assessment will be repeated at regular interval and efficacy assessment will be repeated during every cycles.After the subject completes 6 cycles, there will be a follow-up visit after 4 weeks (+1 week) of study completion.Subjects who have stable disease or who have responded (MR, PR or CR) after completion of the 6 cycles will be given the option to continue treatment for a maximum of 12 cycles or until they are deemed to have progressive disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects.
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India
Shatabdi Superspeciality Hospital
Nashik, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
Delhi, National Capital Territory of Delhi, India
Institute Rotary Cancer Hospital,All India Institute Of Medical Sciences(AIIMS)
New Delhi, New Delhi, India
To determine the maximum tolerated dose of P276-00 in subjects with relapsed and/or relapsed/refractory Multiple Myeloma
Time frame: 18 months
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Netaji Subhash Chandra Bose Cancer Research Institute
Kolkata, West Bengal, India