A Phase II trial of bortezomib and dexamethasone in renally-impaired patients with untreated multiple myeloma.

Phase 2

Recruiting

• Conditions: ntreated Multiple Myeloma patients with renal impairment.; Untreated Multiple Myeloma patients with renal impairment.; Cancer - Myeloma; Blood - Haematological diseases; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12611000605998
• Lead Sponsor: Prof. Andrew Spencer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

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);
*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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified