UMIN-CTR Clinical Trial

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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