Multiple myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Radiolabelled anti-CD66
Product Code: ITC-2B3M-DTPA-BW250/183
Pharmaceutical Form:
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Remission status pre and post transplantation, as defined for multiple myeloma by the European Blood and Marrow Transplantation Organisation (51). Specifically the number of patients in each arm achieving CR as defined in the EBMT response criteria. ;Main Objective: To determine the efficacy of targeted radiotherapy delivered by an Yttrium-90 (90Y)-radiolabelled murine anti-CD66 monoclonal antibody, given in addition to high dose melphalan (200 mg/m2) in terms of disease response (complete remission rate and change of serum free light chan level pre and post yttrium-90-radiolabelled anti-CD66) in patients undergoing haematopoietic stem cell transplantation (HSCT) for multiple myeloma.;Secondary Objective: 1. Determine the toxicity profile of Yttrium90-radiolabelled anti-CD66 MAb in the context of autologous stem cell transplantation. 2. Determine the effect of targeted radiotherapy on parameters of disease reponse, eg proportion of patients with partial remission, stable disease, progressive disease, remission duration (time to disease progression) and overall survival. 3. Determine the effect of targeted radiotherapy on engraftment when used in conjunction with high dose melphalan in patients undergoing autologous peripheral blood stem cell transplantation as treatment for multiple myeloma. 4. Investigate the pharmacokinetic (PK) behaviour of Indium-111 (111In) radiolabelled anti-CD66 MAb in man. 5. Continue to develop a dosimetry model based on SPECT and whole body gamma camera imaging following administration of the radiolabelled anti-CD66 Mab (at the Southampton site only). 6. Assess the proportion of patients that form human anti-murine antibodies (HAMA) | — |
Countries
United Kingdom
Outcome results
None listed