Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000016874
- Lead Sponsor
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open public recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (Phase1)Safety of the VRD treatment<br>(Phase2)Response rate (VGPR + CR + sCR) after the sVRD therapy
- Secondary Outcome Measures
Name Time Method 1. Complete response rate(CR + sCR) after induction therapy. <br>2. Complete response rate(CR + sCR) after autologous stem cell transplantation<br>3. Complete response rate(CR + sCR) after consolidation therapy<br>4. Complete response rate(CR + sCR) after maintenance therapy<br>5. Treatment completion rate <br>6.3 years progression free survival duration<br>7.3 years survival duration<br>8. incidence of adverse events<br>9. Quantity of the stem cell