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.

Not Applicable

Recruiting

• 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

Study Timeline

• Study Start: 2015-03-23
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: Open to public recruiting
• Sex: All
• Target Recruitment: 30

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

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