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

Australiasian Leukaemia and Lymphoma Group0 sites50 target enrollmentSeptember 8, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Australiasian Leukaemia and Lymphoma Group

•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 109/L within one week of starting therapy.
•Platelet count \> \= 50 x 109/L (\>\= 30 x 109/L if MM involvement in the marrow is greater than 50%) within one week of starting therapy, patients should not have received platelet transfusions within one week of the screening platelet count.
•Hb \>\= 80g/L, red cell transfusions as per institutional protocol are allowed.
•Subject must have LVEF \>\= 50% determined by 2\-D transthoracic echocardiogram (ECHO) or Multigated Acquisition Scan (MUGA).
•Has provided written informed consent.

•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
•Patients with myelodysplastic syndrome.
•Known history of allergy to Captisol (registered trademark) (a cyclodextrin derivative used to solubilise carfilzomib)
•Patients with contraindication to dexamethasone.
•Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre\-existing pulmonary or cardiac impairment.
•Women who are pregnant or lactating.
•Active Hepatitis B or Hepatitis C.
•HIV infection, other immunosuppressive therapy or autoimmune disease
•Prior diagnosis of cancer that was: