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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | multiple myeloma | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
h-kosugi@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | ||||||
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 | |
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IRB Contact (For public release) | |
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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 |
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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. |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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