Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Ixazomib Citrate Capsule 4 mg: Dose: 4 mg on Day 01
Treatment Duration: 01 day.
Frequency: Single-Dose (Orally)
Control Intervention1: NINLARO (Ixazomib Citrate) Capsule 4 mg: Dose: 4
Sponsors
Natco Pharma Limited.
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive). 2. Patient with histopathologically/ cytologically confirmed multiple myeloma. 3. Patient with relapsed and/or refractory multiple myeloma who has received at least 1 prior therapy a. This includes patient who relapsed but was not refractory, patient who was refractory to all lines of previous treatment and patient who relapsed from 1 and was refractory to at least one previous treatment. Refractory disease is defined as disease progression within 60 days after the last dose of treatment. b. A line of therapy is defined as 1 or more cycles of a planned treatment program. This consists of 1 or more cycles of single-agent or combination, or sequence of treatments. A planned induction, transplant followed by maintenance is considered 1 line of therapy. Autologous and allogenic transplants are permitted. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Acceptable hematology status: a. Hemoglobin Greater than or Equal to 9 g/dL. b. Absolute neutrophil count (ANC) Greater than or Equal to 1500 cells/microL. c. Platelet count Greater than or Equal to 1,00,000 cells/microL. 6. Acceptable liver function: a. Alanine aminotransferase (ALT) Less than or Equal to 2X Upper Limit Normal (ULN) (Less than or Equal to 5 X ULN for liver metastasis). b. Aspartate aminotransferase (AST) Less than or Equal to 2X ULN (Less than or Equal to 5 X ULN for liver metastasis) c. Total bilirubin Less than or Equal to 1.5 X ULN. d. Alkaline phosphatase Less than or Equal to 2X ULN. 7. Calculated serum creatinine clearance Greater than or Equal to 30 mL/min (using Cockcroft-Gault formula). Formula of creatinine clearance: Crcl is equal to (140 Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl), if female x 85 . 8. Male patient if sexually active with a female of child bearing potential must agree to use barrier method of contraception throughout the study period and for at least 3 months after dosing of study drug. 9. Female with postmenopausal status or female of child bearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 3 months after dosing of study drug. Postmenopausal is defined by any one of the following: a. Postmenopausal with spontaneous amenorrhea for at least one year, or. b. 6 months to 12 months of spontaneous amenorrhea with serum FSH levels Greater than 40 mIU/mL. c. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or. d. Total hysterectomy and an absence of bleeding for at least 3 months. 10. Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations. 11. Patient/LAR willing to provide informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Patient will not be eligible for inclusion in this study if any of the following criteria apply: 1. Patient with a known hypersensitivity to Ixazomib citrate or Lenalidomide or Dexamethasone or any of the excipients of the product. 2. Patient with peripheral neuropathy greater than or equal to Grade 2 the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or higher. 3. QTc (Heart Rate Corrected QT interval) Greater than 450 msec (male) or Greater than 470 msec (female) or family history of long QT syndrome. QT interval will be calculated with Bazett s Formula. 4. Patient with diarrhea Greater than Grade 1, based on the NCI CTCAE Version 5.0 or higher. 5. Patient with serum positivity for Hepatitis B, C or HIV. 6. Concomitant use of strong CYP3A inducers. 7. Systemic antineoplastic or radiation therapy within 21 days prior to randomization. 8. Use of grapefruit and grapefruit containing products within 07 days prior to randomization. 9. Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs within 48 hours prior to randomization. 10. Participation in any investigational drug study within 30 days prior to randomization. 11. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days prior to randomization. 12. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 13. Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery. 14. Patient with history or at risk of venous thromboembolism as per investigator s discretion. 15. Institutionalized patient. 16. Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system. 17. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patient s participation in this study. 18. Any other condition that, in the investigator s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax and AUC168Timepoint: 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| TmaxTimepoint: 1 week | — |
Countries
India
Contacts
Public ContactMr Mohit Vyas
Cliantha Research Limited
Outcome results
None listed