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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007889
Receipt No. R000009290
Scientific Title Low-dose lenalidomide plus dexamethasone after initial therapy with melphalan and prednisone in myeloma patients ineligible for stem cell transplantation
Date of disclosure of the study information 2012/05/05
Last modified on 2017/05/08

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Basic information
Public title Low-dose lenalidomide plus dexamethasone after initial therapy with melphalan and prednisone in myeloma patients ineligible for stem cell transplantation
Acronym Lenalidomide therapy after melphalan/prednisone in elderly patients with new-onset multiple myeloma: LEMON study
Scientific Title Low-dose lenalidomide plus dexamethasone after initial therapy with melphalan and prednisone in myeloma patients ineligible for stem cell transplantation
Scientific Title:Acronym Lenalidomide therapy after melphalan/prednisone in elderly patients with new-onset multiple myeloma: LEMON study
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 safety and efficacy of low-dose lenalidomide plus dexamethasone after melphalan and prednisone in newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PFS
Key secondary outcomes TTP
ORR
CR
OS
safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Low-dose lenalidomide plus dexamethasone (rd) therapy consists of lenalidomide 10 mg/day (day 1-21) and dexamethasone 20 mg/week (day 1, 8, 15, 22). Each cycle is repeated every 4 weeks. This treatment is continued until disease progression, for up to 18 months. Patients receive aspirin (81-100 mg daily) or warfarin as thromboprophylaxis.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient has given voluntary written informed consent
2. Patient was diagnosed with symptomatic multiple myeloma based on IMWG criteria or multiple myeloma on SWOG criteria
3. Quantifiable serum or urine monoclonal protein value
4. Patient is 65 years old or older at study entry or younger patients between 20 and 64 years old who are not candidate to autologous stem cell trasnplantation
5. Patient has a performance status (ECOG) of 0 to 2
6. Patient was treated with melphalan/prednisone as initial therapy. Not meeting criteria for PD. Any of the following:
* < 10% reduction of serum or urine monoclonal protein during MP therapy
* Less than PR after 3 cycles of MP
* Less than VGPR after 6 cycles of MP
* After 9 cycles of MP in patients with a VGPR/CR/sCR after 6 cycles of MP
* Interruption of MP therapy due to toxicity
Key exclusion criteria 1. Acute myocardial infarction within 6 months or deep venous thrombosis/pulmonary thrombosis within 3 years before study entry
2. Active tuberculous disease
3. Poorly controlled insulin-dependent diabetes mellitus
4. Serious psychiatric illness
5. Pregnant or lactating females
6. Any of the following laboratory abnormalities:
* Absolute neutrophil count <= 1.0 x 10~9/L
* Platelet count <= 50 x 10~9/L
* Aspartate transaminase (AST) > 5.0 x the upper limit of normal (ULN)
* Alanine transaminase (ALT) > 5.0 x the ULN
* Serum creatinine >= 3 mg/dl
7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years
8. Positive for HIV antibody

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Harigae
Organization Tohoku University Hospital
Division name Department of Hematology and Rheumatology
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
TEL 022-717-7165
Email harigae@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Onishi
Organization Tohoku University Hospital
Division name Department of Hematology and Rheumatology
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai, Japan
TEL 022-717-7165
Homepage URL
Email yonishi@med.tohoku.ac.jp

Sponsor
Institute Department of Hematology and Rheumatology, Tohoku University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2012 Year 05 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially 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
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
2012 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 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
2012 Year 05 Month 04 Day
Last modified on
2017 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009290

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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