UMIN-CTR Clinical Trial

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
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
Region	Japan

Condition
Condition	Multiple Myeloma
Classification by specialty	Hematology and clinical oncology
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	Medicine
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	75 years-old <=
Age-upper limit	Not applicable
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.
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.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akihiro Yokoyama
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
Email	ayokoyama@ntmc.hosp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Hiromi Ohno
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
Email	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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 06 Month 01 Day

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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date	2014 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 21 Day
Last modified on	2017 Year 04 Month 23 Day

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

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