Multiple myeloma
Conditions
Interventions
The dose increase and decrease judgment in the first and second cohort 1. Three patients are enrolled in the first cohort (level 2). If continuous administration for 12 weeks, three patients will be
Sponsors
Ochanomizu blood study committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 15<= and 70>= (2) Patients with multiple myeloma after autologous peripheral blood stem cell transplantation (3) WBC >3000/mm 3,Neutrophil>1,500/mm 3, hemoglobuin>10g/dl, Platelet>100,000/mm 3 (4) VGRP or CR after autologous peripheral stem cell transplantation (5) More than 6 months after autologous peripheral blood stem cell transplantation (6) PS (ECOG) 0-2 (7) Main organ function is maintenanced (8) Creatinin clearance >= 60ml/min (9) Patients without deep vein thrombosis or pulmonary embolism (10) Signed the informed consent, have the will and ability to follow the protocol
Exclusion criteria
Exclusion criteria: (1) Known hypersensitivity to lenalidomide (2) Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 2 (3) Uncontroled infectious diseases (4) HBs antigen, HCV antibody positive (5) HTLV-I antibody, HCV antibody positive (6) Pregnancy or breastfeeding (7) Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician&#39;s discretion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation of "feasible initial dose level" | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) DLT frecquencies (2) Adverse event frequencies (3) A continuous administration period (4) A complete response rate after lenalidomide administration (3 months) (5) Time to progression | — |
Countries
Japan
Contacts
Public ContactMasahide Yamamoto
Tokyo Medical and Dental University Department of Hematology
Outcome results
None listed