Multiple myeloma
Conditions
Interventions
VES-13 is performed before the start of the study to evaluate frailty. Patients are allocated into two groups according to VES-13 score. 1) Fit group (VES-13 score 0-2) 2) Frail group (VES-13 sc
Cycle 1>
(42days/cycle) Bor 1.3mg/m2 sc days 1, 4, 8, 11, 22, 25, 29, 32 CY 300mg/m2 po days 1, 8, 22, 29 Dex 40mg/day po days 1, 4, 8, 11, 22, 25, 29, 32 <
Cycle 2-4>
(35days/cycle) Bor 1.3mg/m2 sc CY 300mg/m2 po Dex 40mg/day po days 1, 8, 15, 22 Standard sVTD <
Cycle5-8>
(35days/cycle) Bor 1.3mg/m2 sc days 1, 8, 15, 22 Thal 100mg/body po days 1-35 Dex 40mg/day po days 1, 8, 15, 22 2) Frail group regimen Reduced sVCD <
Cycle1-4>
(35days/cycle) Bor 1.3mg/m2 sc days 1, 8, 15, 22 CY 200mg/m2 po days 1, 8, 15, 22 Dex 20mg/day po days 1, 8, 15, 22 Reduced sVTD <
(35days/cycle) Bor 1.3mg/m2 sc days 1, 8, 15, 22 Thal 50mg/body po days 1-35 Dex 20mg/day po days 1, 8, 15, 22
Sponsors
Minato Mirai Hematology Consortium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG) (2)untreated patients without a history of pretreatment, excluding local radiotherapy from pretreatment (3)untreated multiple myeloma patients who diagnosed ineligible for autologous stem cell transplantation. (4)aged more than 20 years old (5)performance status:0-2,or 3 due to osteolytic lesions alone (6)coexisting conditions are eligible as follows: 1)neutrophil count; more than 1,000/mm3 2)platelet count; more than 75,000/mm3 3)serum AST, ALT< 5 times the ULN 4)serum T-Bil< 3 times the ULN 5)serum Cr< 3 times the ULN 6)ejection fraction >= 50% 7)SpO2 >=93% (7)No dysfunctions due to a symptomatic pre-existing sensory neuropathy (NCI-CTCv4.0 Grade 0 or 1) (8)Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method (9)Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
Exclusion criteria
Exclusion criteria: (1)Patients with a past history of allergy to the drug described in the protocol (2)Patients who have had a complication of active double cancer within the past 5 years. (3)HBs antigen positive,HCV antibody positive, HIV antibody positive patients (4) serious mental disorders such as schizophrenia (5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms (6) Patients with severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection (7)Patients with plasma cell leukemia (8)Ptients with thrombosis (9)Women who are or may be pregnant (10)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)overall survival (OS) 2)progression free survival (PFS) 3)complete response rate 4)treatment continuation rate 5)incidence of adverse events 6)comparison of survival between the two treatment groups 7)the relationship between survival and comorbidity indices (CCI, HCT-CI) 8)the relationship between survival and VES-13 9)comparison of the improvement rate in HR-QOL and VES-13 between the two treatment groups 10)the relationship between known prognostic factors and VES-13 11)the relationship between survival and CD56 expression | — |
Countries
Japan
Contacts
Public ContactTomonori Nakazato
Yokohama Municipal Citizen's Hospital Department of Hematology
Outcome results
None listed