Clinical study to learn more about how Kyprolis works to fight against or help to control the disease and if causes side effects in Indian subjects with relapsed or refractory multiple myeloma.
- Conditions
- Health Condition 1: - Health Condition 2: C00-D49- Neoplasms
- Registration Number
- CTRI/2019/06/019535
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
The age limits are being captured as above for the purpose of this CTRI application.
1. Waldenström macroglobulinemia
2. Plasma cell leukemia
3. POEMS syndrome
4. Myelodysplastic syndrome
5. Primary amyloidosis
6. History of other malignancy within the past 5 years, with the following exception[s]:
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Adequately treated breast ductal carcinoma in site without evidence of disease.
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
7. Known immediate or delayed hypersensitivity to Captisol
8. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
9. Intolerance to hydration
10. Active congestive heart failure (NYHA Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant ECHO abnormalities, screening ECG with corrected QTc of >470 msec, pericardial disease, or myocardial infarction within 4 months prior to enrolment
11. Infiltrative pulmonary disease and/or known pulmonary hypertension
12.Active infection within 14 days prior to enrolment
13. Pleural effusions requiring thoracentesis within 14 days prior to enrolment
14. Ascites requiring paracentesis within 14 days prior to enrolment
15. Uncontrolled hypertension
16. Known HIV infection, hepatitis C infection, or hepatitis B infection
17. Ongoing graft-versus-host disease
18. Subject with grade 3 or worse neuropathy within 14 days prior to enrolment
19. Antitumor therapy or investigational agent within 28 days before enrolment or not recovered from any acute toxicity
20. Subjects on immunosuppressive therapy for graft versus host disease
21. Glucocorticoid therapy within 14 days before first dose that exceeds cumulative dose of 160mg of dexamethasone or equivalent dose of other corticosteroids
22. Focal radiation therapy within 7 days prior to enrolment. Radiation therapy to an extended field involving significant volume of bone marrow within 28 days prior to enrolment
23. Autologous stem cell transplant less than 100 days prior to enrolment
24. Prior treatment with Kyprolis (carfilzomib)
25. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study
27. Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after last dose of Kyprolis.
28. Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after last dose of Kyprolis.
29. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 90 days after the last dose of Kyprolis
30. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 90 days
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize safety associated with the <br/ ><br>use of Kyprolis under the locally approved <br/ ><br>label.Timepoint: Protocol specified timepoint (The primary analysis will occur when last subject enrolled has had the opportunity to receive the study treatment for at least 9 months)
- Secondary Outcome Measures
Name Time Method progression free survival, overall response rate, clinical benefit rate, time to response, and duration of response evaluated by Investigator as per local standard procedure using Interntaional Myeloma Working Group - Uniform Response Criteria (IMWG-URC).Timepoint: Length of study