UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low-dose lenalidomide plus dexamethasone after initial therapy with melphalan and prednisone in myeloma patients ineligible for stem cell transplantation
Title of the study (Brief title)	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	Hideo Harigae
Organization	Tohoku University Hospital
Division name	Department of Hematology and Rheumatology
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	Yasushi Onishi
Organization	Tohoku University Hospital
Division name	Department of Hematology and Rheumatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009290