A multicentre single arm study of carfilzomib-thalidomide-dexamethasone (CarTD) for newly diagnosed transplant-eligible multiple myeloma (MM) patients refractory to initial bortezomib-based induction therapy
- Conditions
- Multiple MyelomaCancer - Myeloma
- Registration Number
- ACTRN12615000934549
- Lead Sponsor
- Australiasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 50
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.
Women of childbearing potential must have a negative serum pregnancy test within the 72 hours prior to the first study drug administration.
Women of childbearing potential and male subjects who are sexually active with WOCBP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom.
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:
more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method