Single arm, multicentre study of Carfilzomib in combination with Thalidomide and Dexamethasone (CaTD) in patients with relapsed and/or refractory multiple myeloma (RRMM).
- Conditions
- Multiple MyelomaCancer - Myeloma
- Registration Number
- ACTRN12615000818538
- Lead Sponsor
- Australiasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 91
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 whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) > or = 7500 mg/L (7.5 g/L).
4.Received at least one, but no more than three prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
6.Adequate hepatic function within 28 days prior to registration with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
7.Left Ventricular Ejection Fraction (LVEF) > or = 40%.
8.Absolute neutrophil count (ANC) > or = 1000/mm3 (or 1000 cells/microL) within 21 days prior to registration. Screening ANC should be independent of growth factor support for > or = 1 week.
9.Platelet count > or = 50,000 cells/mm^3 (> or = 30,000 cells/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to registration. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
10.Calculated or measured creatinine clearance (CrCl) of > or =15 mL/min within 21 days prior to registration. Calculation should be based on the Cockcroft and Gault formula
11.Written informed consent in accordance with federal, local, and institutional guidelines.
12.Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test within 21 days prior to registration and agree to use an effective method of contraception during and for 3 months following last dose of drug.
13.Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.
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 congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to registration.
5.Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to registration.
6.Known HIV seropositive and/or untreated hepatitis B (patients with hepatitis B surface antigen [HBsAg] and core antibody [HBcAb] are eligible if receiving adequate antiviral therapy directed at hepatitis B).
7.Patients with known cirrhosis.
8.Active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.
9.Female patients who are pregnant or lactating.
10.Known history of allergy to Captisol (registered trademark) (a cyclodextrin derivative used to solubilise carfilzomib)
11.Patients with hypersensitivity to carfilzomib, velcade, boron, or mannitol.
12.Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to registration.
13.Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to registration.
14.Any other clinically significant medical disease or psychiatric condition that, in the Investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method