UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006182
Receipt number 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 14:21:30

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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 or person

Institute

Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)

Institute

Department

Personal name



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

Value
https://center6.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