Bendamustine, thalidomide and dexamethasone in relapsed/refractory myeloma
- Conditions
- Relpsed or refractory multiple myelomaMedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021451-12-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 95
• Males and females, aged =18 years
• Histologically confirmed multiple myeloma (MM) with measurable disease parameters requiring therapy for relapsed or refractory disease (first relapse or later)
• Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use effective methods of contraception in accordance with (and consent to) the Celgene and Astellas SPC-approved process for thalidomide and bendamustine risk management and pregnancy prevention, or commit to absolute and continuous abstinence. Men must not father a child for up to 6 months following cessation of treatment
• Performance Status (ECOG) 0-3
• Life expectancy at least 3 months
• Able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49
• Pregnant or lactating. Women of child bearing potential must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide risk management and pregnancy prevention.
• Non-secretory MM
• Relapsed on previous bendamustine therapy
• Unsupported platelet count <75 x 10 9/L within 14 days before enrolment (unless attributable to the myeloma in the opinion of the local investigator).
• Absolute neutrophil count <1.5 x10 9/L within 14 days before enrolment.
• Serum bilirubin >2 times upper limit of normal within 14 days before enrolment
• Serum ALT/AST >2.5 times upper limit of normal within 14 days before enrolment
• Calculated or measured creatinine clearance <10 mL/minute within 14 days before enrolment
• =Grade 2 (NCI criteria) peripheral neuropathy within 14 days before enrolment.
• Any history of hypersensitivity to any of the study medications or excipients
• Seropositive for HIV, or active hepatitis A, B or C infection
• Concurrent or previous malignancies (<12 months post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (.=12 months) of other tumours may be entered.
• Evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator’s opinion, preclude entry into the study.
• Poorly controlled hypertension or diabetes mellitus or other serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical study.
• Uncontrolled or severe cardiovascular disease including myocardial infarction 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.
• Received an investigational medicinal product within 28 days of study entry (randomisation or registration)
• Major surgery less than 30 days before start of treatment
• Yellow fever vaccination within 3 month before enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method