ACTRN12611000605998
Recruiting
Phase 2
A Phase II trial of bortezomib and dexamethasone in renally-impaired patients with untreated multiple myeloma.
Prof. Andrew Spencer0 sites28 target enrollmentJune 14, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prof. Andrew Spencer
- Enrollment
- 28
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Renal impairment, secondary to MM, defined as a calculated estimated GFR \<50ml/min,
- •\- Able to provide written informed consent prior to the start of study\-related procedures,
- •\- Subject is, in the investigator's opinion, willing and able to comply with protocol requirements,
- •\- If female, the subject is either post\-menopausal or surgically sterilized or willing to use an acceptable method of birth control from signing of informed consent form through to the final visit/early termination visit.
- •\- If male, the subject agrees to use an acceptable barrier method for contraception from signing of the informed consent through to the final visit/early termination visit.
- •\- The patient meets the following pre\-treatment laboratory criteria at and within 21 days before baseline:
- •\*Platelet count \>50x109/L, with or without transfusion support;
- •\*Haemoglobin \>7\.0g/dL, with or without transfusion support;
- •\*Absolute neutrophil count (ANC)\>/\=2\.0x109/L;
- •\*Serum calcium \<4\.5mmol/L (\<14mg/dL);
Exclusion Criteria
- •\- Use of investigational agents within 28 days of study entry;
- •\- Inadequate hepatic function;
- •\- Severe co\-morbidity or othe likely difficulty in completing the study;
- •\- History of allergic reaction attributable to compounds containing boron or mannitol;
- •\- Peripheral neuropathy or neuropathic pain Grade 2\-4 defined by NCI CTCAE version 3;
- •\- Uncontrolled or severe cardiovascular disease, including M1 within 6 months of enrolment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis;
- •\- Subject has history of hypotension or has decreasing blood pressure (sitting systrolic blood pressure \- Subject has an active uncontrolled systemic infection requiring treatment;
- •\- If female, the subject is pregnant or breastfeeding. Confirmation that the subject is not pregnant must be established by a negative serum beta\-HCG pregnancy test during screening. Pregnancy test is not required for post\-menopausal or surgically steralised women;
- •\- Anyy condition, that, in the opinion of the investigator, would compromise the well\-being of the subject or the study.
Outcomes
Primary Outcomes
Not specified
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