UMIN-CTR Clinical Trial

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

multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Epidemiological and Clinical Research Information Network (ECRIN) (Non-profit Organization)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

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

大垣市民病院（岐阜県）

Date of disclosure of the study information

2011

Year

08

Month

19

Day

URL releasing protocol

Publication of results

Published

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

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 related 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