None listed
Conditions
Brief summary
To study the Quality of Life Assessed by the European Organization of Reseach and Treatment of Cancer (EORTC) disease spesific module and disease free survival and overall survival in patients with mulitple myeloma after Tandem Autologous Stem Cell Transplantation (ASCT) Assessment of patient: 1. Age and sex. 2. Stage of disease initially and at time of recruitment (according to the World Health Organization (WHO) Myeloma Staging System). 3. Type of myeloma disease (M protein): Paraprotein quantification, Serum free light chains, Bence Jones Protein quantification. 4. Skeletal Survey: documentation of all lytic lesions at time of diagnosis and recruitment. 5. Liver and kidney function, C-reactive protein (CRP), Erythrocyte sedmintation rate (ESR), Beta 2 microglobulin (B2M), serum Calcium will be determined at time of the study, and if possible, traced from time of diagnosis. 6. Bone marrow study will be traced from time of diagnosis and relapse when it is possible with documentation of plasma cell content in the bone marrow. 7. Cytogenetic studies will be offered for the patients during routine marrow test to determine the cytogenetic risk factors including 13q- and translocation t(4,14) and its correlation with disease outcome as per our registered trial ACTRN12609000594224. 8. All previous treatments received and response to each treatment should be documented. Monitoring and assessment of quality of life and pain: Quality of life assessment and symptoms, in particular pain, will be assessed quarterly (after initial assessment) and at the end of the study as per the EORTC quality of life questionnaire (QLQ-C30) with disease specific module. In the case of patient willingness to take part in the study, a written consent will be completed, after which the patient will be formally enrolled in the study. Follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant. A clinical assessment form will be filled out at each visit. A full patient profile will be obtained including such detail as medical and drug history, risk factors for multiple myeloma. The patient demographic and physical detail (weight, height etc) will be also measured and recorded. Other routine data and laboratory investigations including kidney and liver function will be recorded. All patients will be counselled that if they decide to withdraw from the study at any time, this will in no way affect their care or procedure at the treatment centre.
Interventions
Assessment of quality of life, tolerability and disease outcome in patients with multiple myeloma undergoing tandem autologous peripheral blood stem cell transplantation (PBSC). The two stem cell transplantation will be conducted 3 months apart with a regular follow up every thre months for 2 years following the second stem cell transplantation. Autologous peripheral blood stem cell transplantation is a technique in which stem cells are obtained from a patient's own peripheral blood stem cells a
Assessment of quality of life, tolerability and disease outcome in patients with multiple myeloma undergoing tandem autologous peripheral blood stem cell transplantation (PBSC). The two stem cell transplantation will be conducted 3 months apart with a regular follow up every thre months for 2 years following the second stem cell transplantation. Autologous peripheral blood stem cell transplantation is a technique in which stem cells are obtained from a patient's own peripheral blood stem cells and used after high-dose melphalan chemotherapy as stem cell transplantation. Previously cryopreserved stem cells are intravenously infused after thawing them into body tempertaure over approximately few minutes one day after the high-dose chemotherapy.
Sponsors
Clifford Craig Medical Research Trust
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients of either gender, 18 years and above who are able to give consent and have either: a confirmed diagnosis of multiple myeloma according to the World Health Organization (WHO) classification or patients who have been enrolled in our protocol with tandem stem cell transplantation
Exclusion criteria
Patient with renal impairment defined by an estimated creatinine clearance below < 15 ml/min based on the Cockcroft-Gault formula. (Creatinine clearance = (140-age) x ideal body weight (IBW in Kg) (x 0.85 if female) / (Serum creatinine. x 0.815). Advanced liver disease (Child C with encephalopathy, ascites and a significantly elevated bilirubin, or pre-treatment coagulopathy). Patients with Eastern Cooperative Oncology Group (ECOG) status>2
Outcome results
None listed