Not available
ACTRN12616001030460
Treatment
Phase 3
Other Collaborative groups,Bristol-Myers Squibb
Prof Andrew Spencer
PURPOSE The primary purpose of this study is to determine the efficacy and safety of elotuzumab when combined with cyclophosphamide, thalidomide and dexamethasone (E-CTD) when compared to a standard cyclophosphamide, thalidomide and dexamethasone (CTD) triplet for the treatment of relapsed and/or refractory multiple myeloma (RRMM) WHO IS IT FOR? You may be eligible to join this study if you are over 18 years, have been diagnosed with RRMM, have had between 1-3 prior lines of therapy (may include .... Read more
1. Male or female patients 18 years or older. 2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 3. Female patients who: - Are postmenopausal for at least 1 year before the screening visit, OR - Are surgically sterile, OR - If they are of childbearing potential, agree to practice 2 effective methods .... Read more
1. Known thalidomide refractory disease or intolerance 2. Patients with monoclonal gammopathy of uncertain significance or smouldering MM. 3. Patients with primary amyloidosis 4. Patients who have had a prior allogeneic transplantation that requires ongoing immunosuppressive therapy 5. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 6. Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the reversible effects o .... Read more
No
Sample Size 300
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Multiple Myeloma
Condition code Cancer
Intervention code Treatment: Drugs
This is a prospective, multi-centre, open-label study, randomised controlled trial of elotuzumab-cyclosphamide-thalidomide-dexamethasone (E-CTD) compared with cyclophosphamide-thalidomide-dexamethasone (CTD). All patients will meet the eligibility criteria at registration and recruitment will continue until 300 patients have been randomised. Randomisation will occur in a 2:1 ratio with 2 patients randomised to the E-CTD arm for every 1 patient randomised to the CTD arm. Patients will not be repl .... Read more
Control group Active
ACTIVE CONTROL ARM (CTD) Cyclophosphamide (500mg oral tablet weekly) + Thalidomide (100mg oral capsule, once daily at night) + Dexamethasone (40mg oral tablet weekly).
Outcome: To determine the progression free survival (PFS) with E-CTD when compared to CTD for the treatment of RRMMTimepoint: PFS will be measured from the date of randomisation to the date of the first documented progression, according to International Myeloma Working Group (IMWG) criteria, or the date of death. At the time of analysis, patients not deemed lost-to-follow-up, will have their PFS censored at the study censor date for PFS (the earliest of the last dates of a .... 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