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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000013773 |
Receipt No. | R000015524 |
Scientific Title | Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld). |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2017/04/23 |
Basic information | ||
Public title | Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld). | |
Acronym | Induction therapy for Myeloma, AlteRnating Bortezomib and LEnalidomide: MARBLE study/2013-NHO(Hematology)-02
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Scientific Title | Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld). | |
Scientific Title:Acronym | Induction therapy for Myeloma, AlteRnating Bortezomib and LEnalidomide: MARBLE study/2013-NHO(Hematology)-02
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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 evaluate the safety and efficacy of Bortezomib-dexamethasone (Bd) alternating with Lenalidomide-dexamethasone (Ld) as induction therapy for newly diagnosed multiple myeloma patients older than 75 years (ineligible for stem cell transplantation). |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Overall response rate (ORR) |
Key secondary outcomes | Safety (toxicity and tolerability)
Continuation rate of treatment Complete response rate Very good partial response rate Progression-free survival rate (PFS) Overall survival rate (OS) Time to response (TTR) |
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 | Bortezomib-dexamethasone (Bd) alternating with Lenalidomide-dexamethasone (Ld) | |
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. Age of patients older than 75 years.
2. Symptomatic multiple myeloma newly diagnosed by WHO criteria, are ineligible for autologous stem cell transplantation. 3. Patients with Measurable disease; M-protein level is more than 0.5g/dL for the IgG, IgA, or IgM type myeloma, M-protein level is more than 0.05g/dL for the IgD type, or urinary M-protein excretion is more than 200 mg/24-hour. 4. Performance status (ECOG) <= 2, or 3 due to osteolytic lesions alone. 5. Have pre-treatment clinical laboratoly values meeting the following criteria: * AST, ALT < 3.0xULN * Creatinine clearance >= 30 mL/min * Absolute neutrophil count (ANC) >= 1.0x10^9/L * Platelet count >= 50x10^9/L * Ejection fraction >= 50% * PaO2 >= 60mmHg or SpO2 >= 93% 6. Agreement to RevMate registration was obtained, patients can comply with the contents. 7. In patients on notice, and received an explanation enough for the contents of this study, patient consent was obtained in writing to participate in the study by the free will. |
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Key exclusion criteria | 1. Plasma cell leukemia, cardiac amyloidosis, POEMS syndrome.
2. Patients has >= Grade 2 peripheral neuropathy. 3. Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension. 4. Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection. 5. Recent operation history. 6. Myocardial infarction within 6 months of enrolment or deep vein thrombosis/ pulmonary embolism within 3 years. 7. Patient has active and advanced double cancer (simultaneous or within 5 years post remission). 8. Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody. 9. Patients with pneumonitis (interstitial pneumonia) or pulmonary fibrosis in clinical, or abnormal (high-resolution) chest CT findings bilateral lung regardless of the presence or absence of symptoms. 10. Patient has hypersensitivity to boron or mannitol. 11. Patient has psychiatric diseases or psychological symptoms. 12. Patient judged inappropriate to participate in this study. |
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Target sample size | 35 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Hospital Organization Tokyo Medical Center | ||||||
Division name | Division of Hematology, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 2-5-1, Higasigaoka, Meguro-ku, Tokyo 152-8902, Japan | ||||||
TEL | 03-3411-0111 | ||||||
ayokoyama@ntmc.hosp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Hospital Organization Tokyo Medical Center | ||||||
Division name | Documents support clerk | ||||||
Zip code | |||||||
Address | 2-5-1, Higasigaoka, Meguro-ku, Tokyo 152-8902, Japan | ||||||
TEL | 03-3411-0111 | ||||||
Homepage URL | |||||||
HOhno@ntmc.hosp.go.jp |
Sponsor | |
Institute | Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO) |
Institute | |
Department |
Funding Source | |
Organization | National Hospital Organization |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization | Japan |
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 | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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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 | Completed | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
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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=R000015524 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |