UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007889 |
|---|---|
| Receipt number | 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 14:01:57 |
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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
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
yonishi@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Hematology and Rheumatology, Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009290
