a study of ps-341 given to patients with multiple myeloma who experienced progressive disease after receiving dexamethasone in m34101-039

Conditions: Multiple Myeloma

Summary: the purpose of this study is to allow patients to receive velcade™ (bortezomib) for injection who experienced progressive disease(pd) while receiving high-dose dexamethasone from the m34101-039 study.

the rationale for amendment 2 is 2-fold. first, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (pd) after receiving the comparator treatment, high-dose dexamethasone, in mpi study m34101-039, thereby ultimately providing all patients who participate in study m34101-039 and require treatment for their disease access to velcade™ (bortezomib) for injection, formerly known as mln341, ldp-341 and ps-341.

Eligibility criteria:
inclusion criteria * patient experienced pd, as defined by swog+ criteria during or after treatment with high-dose dexamethasone in mpi study m34101-039, but has not received alternate anti-neoplastic therapy. intolerance to high-dose dexamethasone therapy as administered in mpi study m34101-039 does not qualify as pd. * patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. * 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. * female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from screening through the end of treatment visit. * male patient agrees to use an acceptable barrier method for contraception from screening through the end of treatment visit. * patient meets the following pretreatment laboratory criteria at and within 14 days before baseline (day 1 of cycle 1, before study drug administration). (note that the end of treatment assessments of mpi study m34101-039 may qualify as the screening assessments for mpi study m34101-040 if performed within 14 days of the baseline visit.): * platelet count ≥20 x 10e+9/l, with or without transfusion support. * hemoglobin ≥7.0 g/dl, with or without transfusion support. * absolute neutrophil count (anc)≥0.5 x 10e+9/l, without growth factor support. * serum calcium \<14 mg/dl (3.5 mmol/l). * aspartate transaminase (ast):≤2.5 x the upper limit of normal (uln). * alanine transaminase (alt):≤2.5 x the uln. * total bilirubin:≤1.5 x the uln. * if calculated or measured creatinine clearance: ≥20 ml/minute, assessments are as specified in the protocol. if calculated or measured creatinine clearance is \<20 ml/minute. exclusion criteria * patient participated in m34101-039 and did not have confirmed pd. dexamethasone intolerance does not qualify as pd. * patient had pd on the dexamethasone arm of the mpi study m34101-039, and then received alternate anti-neoplastic therapy. * patient has not recovered from dexamethasone-related toxicity experienced during mpi study m34101-039. * patient is known to be human immunodeficiency virus (hiv)-positive.(patients assessed by the investigator to be at risk for hiv infection should be tested in accordance with local regulations.) * patient is known to be hepatitis b surface antigen-positive or has known active hepatitis c infection.(patients assessed by the investigator to be at risk for hepatitis b or c infection should be tested in accordance with local regulations.) * female patient is pregnant or breast-feeding. * patient developed a new or experienced worsening of an existing illness during or after completion of study m34101-039 that, in the investigator's opinion, may put the patient at risk of participation in this study.

Keywords: relapsed multiple myeloma refractory multiple myeloma