None listed
Conditions
Brief summary
This study is measuring blood levels of the medication melphalan to improve the way to adjust the dose for people with myeloma. Who is it for? You can join the this study if you have myeloma (a cancer which affects plasma cells in the bone marrow) and are undergoing a bone marrow transplant. Trial details Participants will receive the drug melphalan and will be tested to see how their body breaks down and gets rid of the medication. This study does not replace other studies, but simply investigates key medication widely used in the treatment of myeloma. Participants will be followed for several years after the study to monitor their health. This study will help to define the best way to adjust doses of the drug melphalan, a key medication in helping to control myeloma. Too much causes toxicity and too little risks the disease being more likely to return.
Interventions
This is a multi-institutional study in which a single high dose of melphalan will be administered intravenously over 30 minutes and plasma melphalan concentrations will be measured following the dose to see whether there is a relationship with disease response or toxicity post transplant.. The standard melphalan dose is 200 mg/m2, but some patients will have reduced doses due to renal dysfunction or obesity and this will be according to existing protocols at each participating institution. This
This is a multi-institutional study in which a single high dose of melphalan will be administered intravenously over 30 minutes and plasma melphalan concentrations will be measured following the dose to see whether there is a relationship with disease response or toxicity post transplant.. The standard melphalan dose is 200 mg/m2, but some patients will have reduced doses due to renal dysfunction or obesity and this will be according to existing protocols at each participating institution. This is an observational study with no control group.
Sponsors
The Childrens Hospital at Westmead
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
All myeloma patients scheduled to receive high dose melphalan followed by an autologous transplant.
Exclusion criteria
The only patients that will be exluded from the study are those unable to give informed consent.
Outcome results
None listed