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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006182
Receipt No. R000007315
Scientific Title The clinical trial of Thalidomide maintenance therapy for multiple myeloma patients ineligible for hematopoietic stem cell transplantation.
Date of disclosure of the study information 2011/08/19
Last modified on 2019/02/25

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Basic information
Public title The clinical trial of Thalidomide maintenance therapy for multiple myeloma patients ineligible for hematopoietic stem cell transplantation.
Acronym COnsolidation/MaintEnance with Thalidomide: COMET STUDY/J-MEN 01 STUDY
Scientific Title The clinical trial of Thalidomide maintenance therapy for multiple myeloma patients ineligible for hematopoietic stem cell transplantation.
Scientific Title:Acronym COnsolidation/MaintEnance with Thalidomide: COMET STUDY/J-MEN 01 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 investigate the efficacy and safety of Thalidomide (Thaled capsule 50 or 100) as maintenance therapy after induction chemotherapy for untreated or relapsed/refractory multiple myeloma patients ineligible for hematopoietic stem cell transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (2yr-PFS)
Key secondary outcomes 1. Efficacy
1-1. To assess the overall response rate (ORR)
1-2. To assess the overall survival(OS)
1-3. To assess the progression free survival (PFS)
2. Safety
2-1.laboratory data, vital sign, ECG
2-2. clinical findings
2-3.adverse effect


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Thaled capsule 50 administrated daily for 2-yr after induction therapy.
Interventions/Control_2 Thaled capsule 100 administrated daily for 2-yr after induction therapy.
Interventions/Control_3 The Participants are followed up for 2-yr after induction therapy.
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)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG)
(2)age over 20 years old at the informed consent.
(3)multiple myeloma patients who is untreated or relapsed/refractory treated with less than three regimens. When high dose therapy with ASCT is included in pretreatment, induction therapy to high dose therapy should be counted as 1 regimen.
(4)Performance status: 0-2, or 3 due to osteolytic lesions alone
(5)in the patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained
(6)response rate (RR) after induction therapy is upper SD.
(7)i) leukocyte count; more than 2,000/mm3
ii) neutrophil count; more than 1,000/mm3
iii) platelet count; no more than 50,000/mm3
iv) Less than three times of maximum normal value in AST(GOT)
v) Less than three times of maximum normal value in ALT(GPT)
vi) Less than three times of maximum normal value in serum creatinine
Key exclusion criteria (1)continued treatment and/or prior treatment history with thalidomide
(2)patients treated with other agents of MM as clinical trials or individual import, before induction treatment.
(3)pregnant or nursing women
(4)having prior history or current complications of deep vein thrombosis or pulmonary embolism
(5)serious or uncontrollable active infection
(6)at least HBs-Ag positive or at least HCV-Ab positive, or HIV-Ab positive
(7)Organ dysfunction
(8)uncontrollable involvement (diabetes mellitus, hypertension)
(9)Psychological disturbance: serious disturbance of consciousness, mental illness (schizophrenia, manic depression et al.)
(10)Cardiac dysfunction: serious or uncontrollable cardiac dysfunction
(11)Respiratory dysfunction:
serious or uncontrollable respiratory dysfunction
(12)Those who are considered as inappropriate to register by attending physicians.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kosugi
Organization Ogaki Municipal Hospital
Division name Department of Hematology
Zip code
Address 4-86 minaminokawa-chou, Ogaki, Gifu 503-8502, Japan
TEL 0584-81-3341
Email h-kosugi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Miyashita
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Division name Aichi Branch
Zip code
Address Sanshuya bldg. 2F, 348, kouseicho, Okazaki, Aichi 444-0052, Japan
TEL 0564-66-1220
Homepage URL http://www.omh.ogaki.gifu.jp/gankyoten/clinical_study1/chiryo.htm
Email miya@ecrin.or.jp

Sponsor
Institute Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
Institute
Department

Funding Source
Organization Epidemiological and Clinical Research Information Network (ECRIN) (Non-profit 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 大垣市民病院（岐阜県）

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1007/s12185-019-02607-z
Number of participants that the trial has enrolled
Results 
A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.
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
2011 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 11 Month 20 Day
Date trial data considered complete
2018 Year 11 Month 20 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 17 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007315

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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