ALLG MM18
ACTRN12615000818538
Treatment
Phase 2
Other Collaborative groups,Australasian Leukaemia and Lymphoma Group
Dr Hang Quach
The primary purpose of this study is to determine the efficacy and safety of carfilzomib-thalidomide-dexamethasone (CarTD) therapy for relapsed and/or refractory multiple myeloma (RRMM) patients. Who is it for? You may be eligible to join this study if you are aged over 18 years, have RRMM and have received between one and three lines of therapy previously. Study details The study will recruit participants in Australia and Singapore. All participants will receive 12 x 4-week cycles of CarTD ther .... Read more
1. Male and female patients, > or =18 years of age 2. Relapsed and/or refractory multiple myeloma at study entry. 3. Patients must have evaluable multiple myeloma with at least one of the following (assessed within 21 days prior to registration): a. Serum M-protein > or = 5 g/L, or b. Urine M-protein > or = 200 mg/24 hour, or In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum k/l ratio or For IgA patients .... Read more
1. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to registration, with the exception of dexamethasone up to 160mg or equivalent every 4 weeks. 2. Previous treatment with carfilzomib. 3. Focal radiation therapy within 7 days prior to registration. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to registration (i.e., prior radiation must have been to less than 30% of the bone marrow). 4. Active .... Read more
No
Sample Size 91
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Multiple Myeloma
Condition code Cancer
Intervention code Treatment: Drugs
Carfilzomib will be given in the following schedules, on Days 1,2,8,9,15,16 of a 4-week cycle for cycles 1 to 12 then on days 1,2,15,16 in a 4-week cycle during cycles 13-18. For the first 10 patients from each of Australia and Asia, the dose of carfilzomib will be 20/27 per m^2 (i.e. 20mg/m^2 on Cycle 1 Day 1, escalated to 27mg/m^2 from Cycle 1 Day 8). Safety data will be analysed from each of the cohort of 10 patients from Australia and Asia by the respective sponsor’s trial management committ .... Read more
Control group Uncontrolled
None-single arm
Outcome: To assess the progression free survival (PFS) with combination carfilzomib, thalidomide and dexamethasone (CaTD) in patients with RRMM who have had 1 to 3 prior therapies. PFS measured as per IMWG criteria: Increase of >= 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be >= 0.5 g/dL) Urine M-component and/or (the absolute increase must be >= 200 mg/24 h) Only in patients without measurable s .... Read more
yes
De-identified IPD data for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis