Multiple myeloma
Conditions
Interventions
Control group:VTD regimen+SCT
Expiremental group:PAD regimen+SCT
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provide signed informed consent. 2. Diagnosis of multiple myeloma (MM) according to The guidelines for the diagnosis and management of MM in China (2015 revision), previously untreated. 3. Age = 18 years and < 65 years at the time of enrollment. 4. Measurable disease at screening as defined by any of the following: Serum M-protein =1g/dL (=10 g/L) or 0.5 g/dL (=5 g/L) for subjects with IgA, IgD, IgE, or IgM multiple myeloma; or Urine M-protein level =200 mg/24 hours; or Light chain MM without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (sFLC)=10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =2. 6. Subject meets all of the following laboratory criteria during the Screening Phase: Hemoglobin level =7.5 g/dL ( prior red blood cell [RBC] transfusion or recombinant human erythropoietin use is permitted ) ; Absolute neutrophil count =1.0 × 109/L (granulocyte colony stimulating factor [G-CSF] use is permitted) ; Platelet count =50 × 109/L (transfusion is allowed) ; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) ; Total bilirubin level =1.5 × ULN, except in subjects with congenital bilirubinemia; Creatinine clearance =40 mL/min (may be calculated using the Cockcroft-Gault formula, Modification of Diet in Renal Disease [MDRD] formula or Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula). 7. Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study). 8. A woman of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization. 9. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies. 10. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug. 11. During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository); Male subjects who is sexually active with a woman who is pregnant must use a condom and they must agree not to donate sperm. 12. Females of childbearing potential must agree to avoid pregnancy by using an adequate method of contraception(non-contraceptive drugs) throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed patients who are considered unsuitable for high-dose chemotherapy combined with stem cell transplantation (HD-SCT) for the following reasons: severe comorbidities, is most likely to have a negative effect on the tolerance of HD-SCT, and the patient refuses to take HD-SCT. Need to be judged by the researcher before randomization. 2. Primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma. Patients may be diagnosed with MGUS if they fulfill the following criteria: serum M-protein < 3g/dL; No evidence of bone lesions, anemia, hypercalcemia, or renal insufficiency related to the paraprotein; serum M-protein Plasma cells less than 10% on bone marrow examination. Smoldering multiple myeloma is an asymptomatic clonal plasma cell disorder with no evidence of end-organ damage. 3. Waldenstrom's macroglobulinemia or osteolytic lesions with IgM M-protein but no clonal plasma cell infiltration. 4. Previous or currently accepted multiple myeloma systemic therapy or SCT treatment. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40mg/day for a maximum of 4 days) before treatment. 5. History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years). 6. Radiotherapy within 14 days before randomization. 7. Plasmapheresis within 28 days before randomization. 8. Exhibiting clinical signs of meningeal involvement of multiple myeloma. 9. A. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal. B. Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study). 10. A. Active infection with hepatitis B or hepatitis C. Serologic testing for hepatitis is required at screening, If Hepatitis B surface antigen is positive, the patient will be excluded. Hepatitis B DNA needs to be performed if Hepatitis B core antibody is positive. DNA PCR needs to be confirmed negative prior to randomization in subjects who are Hepatitis B core Ab positive. If Hepatitis C antibody is positive, RNA polymerase chain reaction (PCR) needs to be performed and confirmed negative prior to randomization. B. Known human immunodeficiency virus (HIV) positive. 11. Concurrent medical condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study. 12. Clinically significant cardiac illness, including: Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York He
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VGPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;CR;PFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactWang Yafei
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed