Multiple Myeloma
Conditions
Interventions
No risk factors Lenalidomide 25mg po (day 1-21, every 28 days) Dexamethasone 40mg po/div (day 1,8,15,22, every 28 days) until PD or unacceptable toxicity At least one risk factor (either age 75 o
30mL/min (hemodyalysis is unnecessary): 15mg every a day (day 1-21, every 28 days). CLcr <
30mL/min (hemodyalysis is necessary): 5mg/day (day 1-21, every 28 days)
Sponsors
Iwate Myeloma treatment Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). 2. Measurable M protein in serum or urine. 3. Age from 20 years old. 4. Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.) 5. Main organ function is maintained. 6. Those who are evaluated to be able to survive more than 3 months. 7. For female patients, postmenopause (patients older than one year from the last menstrual period), or the proper way of surgical contraception (birth control pill, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study. 8. In patients receiving the notice, fully briefed for the consent document and other document given explanation about the contents by the study physician or study investigator, agreed writing to voluntarily participate in the study have been obtained.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to lenalidomide. 2. Non-secretory MM and plasma cell leukemia. 3. Patients HIV-positive, HBsAg-positive, HCV-positive. 4. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled hypertension, and uncontrolled infection. 5. Patients with psychiatric disorders. 6. Pregnant women, pre-menopausal women and lactating women. 7. Patients with a history of active malignancy. 8. Those who are considered as inappropriate register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall response rate 2. Incidents of adverse events 3. Discontinuation rate of treatment | — |
Countries
Japan
Contacts
Public ContactShigeki Ito
Iwate Medical University Hospital Hematology/Oncology
Outcome results
None listed