An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Relapsed and/or Relapsed/Refractory Multiple Myeloma
1. Subjects previously diagnosed with multiple myeloma based either on the standard
diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria
as defined in Appendix A.
2. Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior
lines of therapy as defined in Appendix D.
3. Monoclonal protein in the serum of > or = 1 g/dL or monoclonal light chain in the
urine protein electrophoresis of > or = 200 mg/ 24 hours, or measurable light chains
by free light chain assay of > or = 10 mg/dL, or measurable plasmacytoma.
4. Age > or = 18 years at the time of signing the informed consent form
5. ECOG performance status < or = 2
6. Life expectancy > or = 3 months
7. Subjects must have the following laboratory parameters:
- Hemoglobin > or = 8.0 gm/dL
- Absolute Neutrophil Count (ANC) > or = 1000 cells/mm3
- Platelets count > or = 50,000/mm3
- Serum SGOT/AST <3.0 x institutional upper limits of normal (ULN)
- Serum SGPT/ALT <3.0 x institutional upper limits of normal (ULN)
- Serum creatinine <2.5mg/dL
- Serum total bilirubin <1.5 x institutional upper limits of normal (ULN)
8. Woman of childbearing potential [defined as a sexually mature woman who has not
undergone hysterectomy or who has not been naturally postmenopausal for at least 24
consecutive months (i.e. who has had menses any time in the preceding 24 consecutive
months) with a negative serum pregnancy test. In addition, all sexually active women
of childbearing potential and men agreeing to use adequate contraception (hormonal or
barrier method of birth control; abstinence) 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.
9. Ability to understand and the willingness to sign a written informed consent
1. 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 < or = 1) from adverse effects of such therapy received prior
to 4 weeks
2. 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.
3. History of allergic reactions attributed to compounds of similar chemical composition
4. Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction
during the previous 6 months.
5. 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.
6. 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
7. Women who are pregnant or nursing
8. Subjects known to be seropositive for the human immunodeficiency virus or any history
or evidence from physical examination of HIV infection.
9. Subjects requiring the use of concomitant medications that prolong the QT/QTc
interval and/or are known to cause Torsades de Pointes (TdP).
10. Any condition, including laboratory abnormalities, that in the opinion of the
Investigator places the subject at unacceptable risk if he/she were to participate in