KIWI Study- Kyprolis based Induction in untreated Myeloma with Kyprolis post Transplant Consolidatio
- Conditions
- Multiple MyelomaCancer - Myeloma
- Registration Number
- ACTRN12615000188538
- Lead Sponsor
- orth Shore Haematology Clinical Trial Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 50
Disease-related:
1.Newly diagnosed symptomatic multiple myeloma
2.Transplant-eligible (according to local criteria)
Demographic:
3.Age 18- 70years
4.Life expectancy greater than or equal to 3 months
5.Eastern Cooperative Oncology Group (ECOG) performance status 0–2
Laboratory
6.Adequate hepatic function, with serum ALT less than or equal to 3.5 times the upper limit of normal and serum direct bilirubin less than or equal to 34 micromol/L within 14 days prior to enrollment
7.Absolute neutrophil count (ANC) greater than or equal to 1.0 × 109/L within 14 days prior to enrollment
8.Hemoglobin greater than or equal to 80 g/L within 14 days prior to enrollment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
9.Platelet count greater than or equal to 50× 109/L (equal to 30 × 109/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to enrollment
10.Creatinine clearance (CrCl) greater than or equal to 15 mL/minute within 7 days prior to enrollment, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
Ethical/Other
11.Written informed consent in accordance with local, and institutional guidelines.
12.Women of childbearing potential must have a negative serum pregnancy test within the 7 days prior to study drug administration and a negative urine pregnancy test within the 3 days prior to the first study drug administration.
13.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.
Disease-related
1. Multiple Myeloma of IgM subtype.
2. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds a cumulative dose of 160 mg of dexamethasone.
3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
4. Plasma cell leukemia (greater than 2.0 × 109/L circulating plasma cells by standard differential).
5. Waldenstrom macroglobulinemia (WM).
6. Known amyloidosis.
7. Any immunotherapy for myeloma within 21 days prior to enrollment.
Concurrent Conditions
8.Pregnant or lactating females
9.Major surgery within 21 days prior to enrollment(unless related to myeloma)
10.Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment
11.Known human immunodeficiency virus infection
12.Active hepatitis B or C infection
13.Unstable angina or myocardial infarction within 4 months prior to randomization, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
14. Pulmonary Hypertension
15.LVEF of less than 40%
16.Uncontrolled hypertension or uncontrolled diabetes
17.Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
18.Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to enrollment
19.Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
20.Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
21.Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
22.Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess the response rate of patients on this trial<br><br>Blood tests to measure immunoglobulin and serum free light chain values will be performed at the end of each cycle to assess disease response.<br>Bone marrow biopsies will also be performed at 4 time points (at screening, pre-transplant, at day 100 post transplant and on completion of the consolidation phase) to determine the depth of response by measuring minimal residual disease by flow cytometry.[ Upon completion of post-transplant consolidation therapy]
- Secondary Outcome Measures
Name Time Method