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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000004421 |
Receipt No. | R000005281 |
Scientific Title | Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma. |
Date of disclosure of the study information | 2010/10/20 |
Last modified on | 2018/08/17 |
Basic information | ||
Public title | Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma. | |
Acronym | JSCT-MM10 | |
Scientific Title | Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma. | |
Scientific Title:Acronym | JSCT-MM10 | |
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 | To investigate efficacy and safety of Bortezomib and dexamethasone as re-induction therapy in patients with non-response to high dose dexamethasone therapy.
To investigate efficacy and safety of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Probability of CR+VGPR after lenalidomide plus dexamethasone consolidation therapy. |
Key secondary outcomes | 1.Probability of CR+VGPR after lenalidomide maintenance therapy.
2.time to progression (TTP) 3.2-years progression free survival (PFS) 4.2-years overall survival (OS) 5.Incidence of adverse events |
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 | High dose dexamethasone therapy(one course):Dexamethasone 40mg/body po or iv(day 1-4,9-12,17-20)
Bortezomib plus dexamethasone therapy(up to 4 courses):Bortezomib 1.3mg/m2 iv (day1,4,8,11).Dexamethasone 20mg/body po (day1,2,4,5,8,9,11,12) PBSC harvest:Cyclophosphamide 2g/m2 div (day1,2) High dose Chemotherapy (L-PAM) and PBSCT:L-PAM 100mg/m2 div (day-3,-2). PBSCT(day0) Lenalidomide plus dexamethasone therapy (2 courses): Lenalidomide 25mg/body po (day1 to 21). Dexamethasone 40mg/body po (day1,8,15,22). Lenalidomide maintenance therapy (one year): Lenalidomide 10mg/body po (day1 to 21) |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG)
2.Measureable M protein in serum or urine. 3.Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.) 4. Age from 20 to 65 years old. 5.Main Organ function is maintained 6. Those who are evaluated to be able to survive more than 3 months. 7.For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study. 8.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 have been obtained. Bortezomib plus dexamethasone therapy (at the second registration) 1. The efficacy evaluation after high dose dexamethasone therapy is under VGPR. 2. Good performance status (0-2). 3. Main Organ function is maintained. 4. Those who are evaluated to be able to survive more than 3 months. |
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Key exclusion criteria | 1.Peripheral neuropathy (>=grade 2)
2.Prior high dose dexamethasone therapy caused severe adverse events as follows; Liver dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection. 3.Patient was suspected pneumonia (Interstitial pneumonia) by high dose dexamethasone therapy. (Consult a respiratory specialist if necessary) 4.Those who are considered as inappropriate to register by attending physicians. |
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Target sample size | 37 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Hospital Organization Okayama Medical Center | ||||||
Division name | Division of Hematology | ||||||
Zip code | |||||||
Address | Okayama, Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | JSCT | ||||||
Division name | MM10 datacenter | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
jsct-office@umin.ac.jp |
Sponsor | |
Institute | Japan Study Group for Cell Therapy and Transplantation |
Institute | |
Department |
Funding Source | |
Organization | Resarch Foundation for Community Medicine |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
Registered date |
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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=R000005281 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |