A multicentre single arm study to evaluate the safety and efficacy of carfilzomib-thalidomide-dexamethasone (CarTD) for newly diagnosed transplant-eligible multiple myeloma (TE NDMM) patients refractory to initial bortezomib-based induction therapy (MM17)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 50 patients with newly diagnosed, transplant eligible, multiple myeloma using carfilzomib-thalidomide-dexamethasone (CarTD), in a randomised trial Demographic data, diagnostic data, treatment data, outcome data
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Chemotherapy |

Source Study


Commercial sector/Industry,Onyx Pharmaceuticals Inc., a subsidiary of Amgen, Inc.

Scientific enquiries

Prof Andrew Spencer

Brief Summary

The primary purpose of this study is to determine the efficacy and safety of carfilzomib-thalidomide-dexamethasone (CarTD) therapy for newly diagnosed transplant-eligible multiple myeloma (NDMM) patients who did not respond adequately to initial bortezomib-based therapy. Who is it for? You may be eligible to join this study if you are aged over 18 years, have been diagnosed with symptomatic NDMM as per International Myeloma Working Group (IMWG) criteria, are eligible for high-dose melphalan cond ....
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Key Inclusion Criteria

Male and Female patients, >17 years of age. Symptomatic NDMM as per IMWG criteria. Eligible for high-dose melphalan conditioned ASCT. Failed to achieve at least a minimal response (MR) with a minimum of 2 cycles of a prior bortezomib-based induction therapy or a partial response (PR) with a minimum of 4 cycles of a prior bortezomib-based induction therapy. Adequate liver function (total bilirubin < 1.5 ULN, ALT < 2.5x ULN) unless considered secondary to MM. Absolute neutrophil count > = 1.0 x 10 ....
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Key Exclusion Criteria

Patients who have had myocardial infarction within 6 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities Other uncontrolled intercurrent illness including, but not limited to, severe active infection, or psychiatric illness/social situations that would limit compliance with study requirements Pati ....
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Can healthy volunteers participate?




Sample Size    50

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Multiple Myeloma

Condition code    Cancer


Intervention code Treatment: Drugs

SALVAGE: Carfilzomib will be given by IV infusion over 30 minutes on Days 1, 2, 8, 9, 15, 16 of each 4-week cycle for 4 cycles. Carfilzomib 20 mg/m2 will be delivered on Cycle 1 Day 1 and 2 and then escalated to 56 mg/m2 from Cycle 1 Day 8 onwards. Thalidomide will be given continuously at a starting dose of 100mg oral daily starting on Day 1, Cycle 1 for the duration of the cycle. Dexamethasone will be given at a dose of 20mg orally on days 1, 2, 8, 9, 15 and 16 of each 4 week cycle prior to ca ....
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Control group Uncontrolled

Single arm


Outcome: To determine the overall response rate (ORR) to treatment with Car-TD salvage therapy in TE NDMM patients who have had a sub-optimal response to a bortezomib-based induction therapy. The ORR will be calculated as the number of patients who have experienced at least a partial response prior to ASCT, divided by the number of patients registered on the trial.
Timepoint: The primary efficacy analyses will be conducted after all patients, have completed pre-ASCT salvag ....

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Outcome: To evaluate the composite primary outcome of tolerability and safety profile of Car-TD salvage therapy when administered to TE NDMM patients who have had a sub-optimal response to a bortezomib-based induction therapy. The co-primary outcome of the trial is to evaluate the tolerability and safety of Car-TD salvage therapy. The co-primary objective of the trial is to evaluate the tolerability and safety of Car-TD salvage therapy. These evaluations will be conducted on the ....
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The data-sharing statement for this study is currently unavailable.

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