A Phase II trial of bortezomib and dexamethasone in renally-impaired patients with untreated multiple myeloma.
Prof. Andrew Spencer
28 participants
Apr 8, 2011
Interventional
Conditions
Summary
This study aims to document the rate of renal response and reversal of renal impairment secondary to untreated multiple myeloma (MM) following treatment with Bortezomib and Dexamethasone. This will be done by blood analysis. Patients with untreated multiple myeloma will be selected by physicians. To ensure eligibility to go on trial the patients are required to undergo various blood tests, bone marrow aspirate ad doctor's review before commencing on this treatment. Who is it for? You may be eligible for this study if you are 18 years and over, have renal impairment secondary to MM, defined as a calculated estimated GFR <50ml/min. You must also provide written informed consent prior to the start of study-related procedures. Further details as to whether you are eligible for this study can be found in the inclusion and exclusion criteria within this trial record. Trial details Once you are deemed eligible to take part in this study, you will commence a 21 day cycle of Bortezomib 1.3mg/m2 IV given on days 1, 4, 8, and 11 and Dexamethasone 20mg oral on days 2, 4, 5, 8, 9, 11 and 12 on a 21 day cycle. If your disease does not achieve at least a partial remission after 2 cycles of therapy or shows disease progression at any time, you will be withdrawn from the trial. If you are eligible for high-dose chemotherapy conditioned stem cell transplant and have been responding to therapy, you will receive 4 cycles of therapy before proceeding to your transplant. If you are not eligible for a transplant, you will receive a maximum of 11 cycles of therapy except if you complete remission sooner, in which case you will have Bortezomib therapy ceased after two further cycles and therefore may receive less than 11 cycles of therapy. Treatment efficacy will be monitored throughout the study, at the end of each cycle and at the discretion of your treating doctors.
Eligibility
Inclusion Criteria14
- 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);
- Aspartate Transaminase (AST) <2.5x the upper limit of normal;
- Alanine transaminase (ALT): <2.5x the upper limit of normal;
- Total bilirubin: <1.5x the upper limit of normal (exceptions will be made for patients diagnosed with Gilbert Syndrome);
- ECOG status 0-3.
Exclusion Criteria10
- 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 </=100mm/Hg and/or sitting diastolic blood pressure </=60mmHg;
- 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.
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Interventions
Bortezomib 1.3mg/m2 IV on days 1, 4, 8, and 11. Dexamethasone 20mg oral on days 2, 4, 5, 8, 9, 11 and 12 on a 21 day cycle. Patients whose disease does not achieve at least a partial remission after 2 cycles of therapy or shows disease progression at any time will be withdrawn from the trial. Patients eligible for high-dose chemotherapy conditioned stem cell transplant and who are responding to therapy will receive 4 cycles of therapy before proceeding to transplant. Non transplant eligible patients will receive a maximum of 11 cycles of therapy except those who achieve complete remission sooner who will have bortezomib therapy ceased after two further cycles and therefore may receive less than 11 cycles of therapy.
Locations(1)
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ACTRN12611000605998