Single arm, multicentre study of Carfilzomib in combination with Thalidomide and Dexamethasone (CaTD) in patients with relapsed and/or refractory multiple myeloma (RRMM) - MM18

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

- MM18 is an International study in collaboration with Asian Myeloma Network (AMN). - The overall number of participants planned was 100 (50 patients from ALLG sites and 50 from AMN sites). - Overall, the trial recruited 93 patients altogether (50 patients from ALLG sites and 43 patients from AMN sites). - The study included male and female patients, ≥18 years of age (*For Singapore, Male and female patients, ≥21 years of age). - This study was aimed for relapsed and/or refractory multiple myeloma with up to 3 lines of prior treatment. - The study aimed to assess the progression free survival in patients with RRMM who have had 1 to 3 prior therapies treated with combination carfilzomib, thalidomide and dexamethasone. Data types - Data set included 90 patients, as 3 patients were excluded due to screen failures. Cancer Australia demographic data -Year of birth -Aboriginal or Torres Strait Islander status (or Ethnicity) - Disease response collected as per IMWG criteria - Quality of life (EuroQoL EQ-5D-5L) was collected - Follow up data collected every 12 weeks. - ECOS performance status was assessed for all 90 patients throughout the study until follow up. - There were 2 interim analyses and a main analysis conducted. The first interim analysis was conducted on 02 August 2017 with 10 participants on study to assess safety. The second interim analysis was conducted on 28 April 2020. The analysis population for the second interim analysis was all patients that received at least one dose of carfilzomib and who could be assessed for the primary endpoint of PFS. Overall, 68 patients were evaluated for the second interim analysis (49 from Australia and 19 from Asian Myeloma Network). The final analysis was conducted on 12 May 2023 following the completion of the last patient’s final cycle of maintenance treatment.
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Chemotherapy |

Source Study


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

Dr Hang Quach

Brief Summary

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 ....
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Key Inclusion Criteria

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 ....
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Key Exclusion Criteria

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 ....
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Can healthy volunteers participate?




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 ....
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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 ....
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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