A Multicentre Phase 3 Trial Comparing Elotuzumab-Cyclophosphamide-Thalidomide-Dexamethasone (E-CTD) with Cyclophosphamide-Thalidomide-Dexamethasone (CTD) for the Treatment of Relapsed and/or Refractory Multiple Myeloma (RRMM) (MM20)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 110 patients with relapsed or refractory multiple myeloma, in a randomised controlled trial of Elotuzumab-Cyclophosphamide-Thalidomide-Dexamethasone (E-CTD) with Cyclophosphamide-Thalidomide-Dexamethasone (CTD) Demographic data, diagnostic data, treatment data, outcome data
Click to explore relationships graph


Chemotherapy |

Source Study


Other Collaborative groups,Bristol-Myers Squibb

Scientific enquiries

Prof Andrew Spencer

Brief Summary

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

Key Inclusion Criteria

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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 3.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

Key Exclusion Criteria

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

Can healthy volunteers participate?




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 RRMM
Timepoint: 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

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

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.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see