Multiple myeloma
Conditions
Interventions
1) Phase I The MTD of bortezomib and lenalidomide with dexamethasone will be determined according to a 3 + 3 dose-escalation scheme. The MTD will be evaluated within 2 cycles of treatment. During th
Sponsors
Fukuoka Blood and Marrow Transplantation Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Relapsed or refractory myeloma after at least 1 treatment regimen. 2) Measureable M protein in serum or urine. 3) ECOG performance status of 0 to 2 (Patients with PS 3 restricted by bone lesions are allowed to participate) 4) Age older than 20 years 5) Adequate organ function 6) A life expectancy of at least 3 months 7) Female patients with post menoposal status and the last menstrual period>12 months prior to enrollment in trial, or patients who agree to contraception during the study. 8) Voluntary written informed consen
Exclusion criteria
Exclusion criteria: 1) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0). 2) Those who can not receive bortezomib subcutaneously at a dose of 1.3 mg/m2 3) History of hypersensitivity to lenalidomide, bortezomib, dexamethasone, mannitol or boron. 4) Nonsecretory multiple myeloma, solitary plasmacytoma, plasma cell leukemia or POEMS syndrome. 5) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C. 6) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases) 7) History of active malignancy during the past 5 years 8) Psychoneurotic disorder, depression state or history 9) Pregnant or lactating female 10) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities. 11) Those who are considered as inappropriate to register by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Phase I To determine the maximum tolerated dose (MTD) of subcutaneous bortezomib administrated once weekly, lenalidomide administrated for 3 weeks when combined with dexamethasone in a 28-day schedule. 2) Phase II To investigate the efficacy of a 8 cycles of subcutaneous bortezomib, lenalidomide and dexamethasone at the recommended dose level determined by the phase I trial. | — |
Countries
Japan
Contacts
Public ContactToshihiro Miyamoto
Fukuoka Blood and Marrow Transplantation Group RRMM-sVRd14 DC
Outcome results
None listed