A trial to determine the effectiveness of targeted radiotherapy in stem cell transplantation.
- Conditions
- Multiple myelomaMedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-003424-12-GB
- Lead Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
• Histologically or cytologically proven multiple myeloma.
• In PR after chemotherapy and before priming therapy for stem cell mobilization.
• Age greater than 18 years.
• Life expectancy of at least 24 weeks.
• World Health Organisation (WHO) performance status of < 2 (Appendix 1).
• Haematological and biochemical indices (These measurements must be performed within one week prior to the patient going on study.)
-Haemoglobin (Hb) = 9.0 g/dl
-neutrophils = 1.5 x 109/L
-platelets (Plts) = 50 x 109/L
• Any of the following abnormal baseline liver function tests :
-Serum bilirubin = 1.5 x upper normal limit
-Alanine amino-transferase (ALT)
-and/or aspartate amino-transferase (AST) = 2.5 x upper limit of normal (ULN) unless due to tumour in which case up to 5 x ULN is permissible
• The following abnormal baseline renal function test:
-calculated creatinine clearance = 50 ml/min (uncorrected value)
-or isotope clearance measurement = 50ml/min
• No concurrent or recent (within 4 weeks) chemotherapy for the underlying haematological condition (excluding cyclophosphamide priming for stem cell harvest). This does not include thalidomide which is permitted.
• Although the BM remission status is not important, patients must have cellularity > 20%.
• Patients must have sufficient stem cells in cryo-storage for two transplant procedures, this is in case graft failure occurs as a result of therapy.
• Patients must be negative for human anti-mouse antibodies (HAMA).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment.
• All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and LRF should not exclude the patient.
• Patients with BM cellularity < 20%.
• Patients who test positive for HAMA.
• Previous high dose therapy and autologous stem cell transplant.
• Patients in CR after chemotherapy and prior to APBSCT.
• Pregnant and lactating women are excluded.
• Major thoracic and/or abdominal surgery in the preceding three to four weeks from which the patient has not yet recovered.
• Patients who are high medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.
• Patients with any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
• Patients known to be serologically positive for Hepatitis B, C or HIV.
• History of Allergy. In particular a history of allergy to rodents or rodent proteins.
• History of eczema, asthma.
• Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease (refer to Appendix 5)
• Patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health.
Less than 4 x 106 CD34 positive cells per kg body weight.
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