multiple myeloma
Conditions
Interventions
Thaled capsule 50 administrated daily for 2-yr after induction therapy.
Thaled capsule 100 administrated daily for 2-yr after induction therapy.
The Participants are followed up for 2-yr after induct
Sponsors
Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG) (2)age over 20 years old at the informed consent. (3)multiple myeloma patients who is untreated or relapsed/refractory treated with less than three regimens. When high dose therapy with ASCT is included in pretreatment, induction therapy to high dose therapy should be counted as 1 regimen. (4)Performance status: 0-2, or 3 due to osteolytic lesions alone (5)in the patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained (6)response rate (RR) after induction therapy is upper SD. (7)i) leukocyte count; more than 2,000/mm3 ii) neutrophil count; more than 1,000/mm3 iii) platelet count; no more than 50,000/mm3 iv) Less than three times of maximum normal value in AST(GOT) v) Less than three times of maximum normal value in ALT(GPT) vi) Less than three times of maximum normal value in serum creatinine
Exclusion criteria
Exclusion criteria: (1)continued treatment and/or prior treatment history with thalidomide (2)patients treated with other agents of MM as clinical trials or individual import, before induction treatment. (3)pregnant or nursing women (4)having prior history or current complications of deep vein thrombosis or pulmonary embolism (5)serious or uncontrollable active infection (6)at least HBs-Ag positive or at least HCV-Ab positive, or HIV-Ab positive (7)Organ dysfunction (8)uncontrollable involvement (diabetes mellitus, hypertension) (9)Psychological disturbance: serious disturbance of consciousness, mental illness (schizophrenia, manic depression et al.) (10)Cardiac dysfunction: serious or uncontrollable cardiac dysfunction (11)Respiratory dysfunction: serious or uncontrollable respiratory dysfunction (12)Those who are considered as inappropriate to register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (2yr-PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy 1-1. To assess the overall response rate (ORR) 1-2. To assess the overall survival(OS) 1-3. To assess the progression free survival (PFS) 2. Safety 2-1.laboratory data, vital sign, ECG 2-2. clinical findings 2-3.adverse effect | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical Research Information Network (ECRIN) Aichi Branch
Outcome results
None listed