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.

UMIN ID: UMIN000016874

Registered date:23/03/2015

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 2015/04/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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
･Lenalidomide 25mg/body po day1-21
･Dexamethasone 20mg/body po day1,8,15,22

2.Stem cell harvest and Autologous stem cell transplantation
Harvest
･Cyclophosphamide 1.5g/m2 div day1,2
･G-CSF sc day-5

Transplantation
･L-PAM 100mg/m2 div day-2,-1
･PBSCT day0

3.Consolidation therapy
Rd 4cycle(every 28 days)
･Lenalidomide 25mg/body po day1-21
･Dexamethasone 20mg/body po day1,8,15,22

4.maintenance therapy
R 24cycle(every 28 days)
･Lenalidomide 10mg/body po day1-21

Outcome(s)

Primary Outcome

(Phase1)Safety of the VRD treatment
(Phase2)Response rate (VGPR + CR + sCR) after the sVRD therapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
• Source(s) of Monetary Support: none