Multiple myeloma
Conditions
Interventions
ICD-id group:Ixazomib plus Cyclophosphamide and Dexamethasone
RCD-rd group:Lenalidomide plus Cyclophosphamide and Dexamethasone
Sponsors
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or female patients from 65 to 79 years old or younger not eligible for transplantation. 2. Newly diagnosed multiple myeloma based on standard CRAB criteria, Patient has measurable disease, defined as follows according to the central laboratory: Serum M- protein >= 1g/dL (>= 10 g/L), serum M- protein >= 0.5 g/dL (>= 5 g/L) in case of IgA, IgD, IgE or IgM multiple myeloma subjects, or urine M- protein level >= 200 mg/24 hours; if there is no light chain multiple myeloma of measurable focus in the serum and urine samples of subjects: serum immunoglobulin free light chain >= 10 mg/dL, and serum immune The ratio of free light chain was abnormal. 3. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 0, 1 or 2 for 65 years old; 0, 1 or 2 for 65-75 years old; 0 or 1 for 75-79 years old; 4. Patients must meet the following clinical laboratory criteria: 1) Absolute neutrophil count (ANC) >= 1,000/mm3 and platelet count >= 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. 2) Total bilirubin = 30 mL/min (see Appendix 11.7). 5) Haemoglobin >= 8 g/dL. 5. Female patients who: Are postmenopausal for at least 1 year before the screening visit, or Are surgically sterile, or If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, and Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). 6. Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). 7. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 8. Patients are willing and able to comply with the study visit plan and other protocol requirements, including blood sampling and bone marrow puncture.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: 1. Patients have been treated with 14 days before erollment except for short-term (dexamethasone dose 40 mg / day or equivalent, up to 4 days) corticosteroid treatment before treatment. 2. Radiotherapy within 14 days before enrollment. 3. Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 4. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 5. Major surgery within 14 days before enrollment. 6. Central nervous system involvement. 7. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. 8. Diagnosis of Waldenstroms macroglobulinemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome. 9. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. 10. Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. Johns wort . 11. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive (HBV-DNA and HCV-RNA will be analyzed (anti-HBsAg, anti-HBeAg, anti-HBcAg, HBsAg, HBeAg, anti-HCV) to evaluate the cell proliferation of virus; anti-HIV antibody must be negative). 12. With systemic disease or other serious complications, the researchers believe that patients are not suitable for entering this study, (such as level 1 with pain, or level 2 or higher grade PN for any reason). 13. Any serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol. 14. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 15. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib/lennalidomide including difficulty swallowing. 16. Participation in other clinical trials with 30 days before erollment 17. Plasma cell leukemia (according to the World Health Organization standard: plasma cell in peripheral blood >= 20%, absolute plasma cell count >= 2 x 10^9 / L) or poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin lesions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (PR+VGPR+CR); | — |
Countries
China
Contacts
Public ContactJianqing Mi
Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed