Multiple myeloma
Conditions
Interventions
1.induction therapy
sVD 1cycle(every 21 days)
?Bortezomib 1.3mg/m2 sc day1,4,8,11
?Dexamethasone 20mg/body po day1,4,8,11
sVRD 4cycle(every 35 days)
?Bortezomib 1.3mg/m2 sc day1,8,15,22
?Lenalidomi
Sponsors
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.multiple myeloma defined by IMWG criteria. 2.aged from 20 to 65 years old. 3.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.) 4.Main organ function is maintained Absolute neutrophil counts >1000/mm Platelet counts>75,000/mm3 T-bil < 3 times upper limit of normal standard AST and ALT < 5 times upper limit of normal standard Serum Creatinine <2mg/dl EF >50% SaO2 >93% 5. The patient who lives more than three months 6. The patient who can follow the RevMate 7. In 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 having been obtained. 8.The HBc antibody and HBs antibody-positive patient is eligible for guidelines on conformity
Exclusion criteria
Exclusion criteria: 1.non-secretary multiple myeloma or plasmacytoma or plasma cell leukemia, POEMS syndrom 2.HBs antigen,HCV antibody positive 3.HTLV-1 antibody, HIV antibody positive 4.Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 5.Patients with a history of active malignancy during the past 5 years. 6.Patients with psychiatric disorders such as schizophrenia etc. 7.Pregnant women, pre-menopausal women, and lactating women. 8.History of hypersensitivity to mannitol or boron. 9.dialysis patient 10.Patient of the vein thrombosis 11.Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary 12.Those who are considered as inappropriate to register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Phase1)Safety of the VRD treatment (Phase2)Response rate (VGPR + CR + sCR) after the sVRD therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response rate(CR + sCR) after induction therapy. 2. Complete response rate(CR + sCR) after autologous stem cell transplantation 3. Complete response rate(CR + sCR) after consolidation therapy 4. Complete response rate(CR + sCR) after maintenance therapy 5. Treatment completion rate 6.3 years progression free survival duration 7.3 years survival duration 8. incidence of adverse events 9. Quantity of the stem cell | — |
Countries
Japan
Outcome results
None listed