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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000016874 |
Receipt No. | R000019585 |
Scientific Title | 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. |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2018/06/01 |
Basic information | ||
Public title | 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. | |
Acronym | VRD-study | |
Scientific Title | 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. | |
Scientific Title:Acronym | VRD-study | |
Region |
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Condition | ||
Condition | Multiple myeloma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | (Phase1)Safety of the VRD treatment
(Phase2)Response rate (VGPR + CR + sCR) after the sVRD therapy |
Key secondary outcomes | 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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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 |
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Interventions/Control_2 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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 |
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Key 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. |
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Target sample size | 30 |
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Name of lead principal investigator |
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Organization | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | ||||||
Division name | Dept.Laboratory | ||||||
Zip code | |||||||
Address | 1-9-6,Senda-machi,Naka-ku,Hiroshima | ||||||
TEL | 082-241-3111 | ||||||
blood@hiroshima-med.jrc.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | ||||||
Division name | Dept.Hematology | ||||||
Zip code | |||||||
Address | 1-9-6,Senda-machi,Naka-ku,Hiroshima | ||||||
TEL | 082-241-3111 | ||||||
Homepage URL | |||||||
mitagaki@hiroshima-med.jrc.or.jp |
Sponsor | |
Institute | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital |
Institute | |
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Funding Source | |
Organization | none |
Organization | |
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Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019585 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
Registered date | File name |