UMIN-CTR Clinical Trial

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

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

PFS

Key secondary outcomes

TTP
ORR
CR
OS
safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Hematology and Rheumatology, Tohoku University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

05

Month

05

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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