UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009391
Receipt number R000010590
Scientific Title Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study
Date of disclosure of the study information 2012/11/24
Last modified on 2019/06/03 17:48:52

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Basic information

Public title

Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study

Acronym

RefLEX-study
Therapy for Refractory or relapsed elderly myeloma with Lenalidomide, cyclophosphamide (Endoxan) and deXamethasone.

Scientific Title

Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study

Scientific Title:Acronym

RefLEX-study
Therapy for Refractory or relapsed elderly myeloma with Lenalidomide, cyclophosphamide (Endoxan) and deXamethasone.

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 safety and efficacy of the combination therapy with lenalidomide, cyclophosphamide, and dexamethasone as induction therapy for relapsed or refractory geriatric multiple myeloma patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Maximum tolerated dose, incidence of adverse events, duration of therapy

Key secondary outcomes

Best response rate, duration of response, progression free survival, overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Phase I dose-escalation trial of cyclophosphamide which involves three cohorts.

Cohort1:lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 200mg/day (Days 1, 8, 15, 22))
Cohort2: lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 300mg/day (Days 1, 8, 15, 22))
Cohort3: lenalidomide 15mg/day (Days 1-21), dexamethasone 40mg/day (Days 1, 8, 15(or 22), cyclophosphamide 400mg/day (Days 1, 8, 15, 22))

every five weeks, two to six cycles

Interventions/Control_2


Interventions/Control_3


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

70 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) Relapsed and refractory myeloma after at least 1 treatment regimen.
3) Aged more than 70 years old
4) Karnofsky performance status more than 70%,(ECOG PS:0-1)
5) Coexisting conditions are eligible as follows:
A.bone marrow function;
a) neutrophil count; more than 1,000/mm3,
b) platelet count; more than 50,000/mm3, c) hemoglobin count; more than 7.0g/dL,
B.liver function;
a) less than two times of maximum normal value in AST and ALT,
b) less than two times of maximum normal value in total bilirubin
C.renal function;
a) less than two times of maximum normal value in serum creatinine,
D.cardiac function;
a) no ECG abnormalities (more than 450msec in QTc elongation, any cardiac ischemia and atrial fibrillation and ventricular arrhythmias.
b) more than 50% in ejection fraction of left ventricle.
E.respiratory function;
a) no abnormalities in chest X-ray
6) no severe peripheral neuropathy, neuropathic pain and functional loss (Gr 0, or 1 in NCI-CTCv4.0).
7) 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
8) Male patients who agree to contraception by contraceptive operation or other appropriate method

Key exclusion criteria

1) untreated patients without a history of pretreatment
2) patients with a past history of allergy to the drugs described in the protocol
3) patients with a past history of using lenalidomide
4) patients who are expected to be need radiation against local disease or for palliative therapy, at registration.
5) patients who have any amyloidosis
6) patients who have uncontrollable diabetes mellitus
7) patients with a past history of angina or myocardial infarction and who have arrhythmia treated with anti-arrhythmic.
8) patients with a past history of cerebral infarction.
9) patients with a past history of venous or arterial thrombosis.
10) patients who have or suspected of having a serious active infection
11) patients who have renal failure, requiring hemodialysis.
12) patients who have liver cirrhosis, diagnosed biopsy or clinical data.
13) patients who have had a complication of active double cancer* within the past 5 years * Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment or lesions corresponding to intramucosal carcinoma (excluding cervical carcinoma presenting in FIGO Stage I)
14) positive test for HBs antigen or HCV antibody or HIV antibody.
15) patients who use major tranquilizer, antidepressant, or antimanic drugs.
16) patients who have serious mental disorders such as schizophrenia
17) other patients who are in the opinion of the caring investigator, unfit for enrollment in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Sasaki

Organization

Juntendo Univ.

Division name

Division of Hematology

Zip code


Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

msasaki@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Makoto Sasaki

Organization

Juntendo Univ.

Division name

Division of Hematology

Zip code


Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

msasaki@juntendo.ac.jp


Sponsor or person

Institute

KT-MM

Institute

Department

Personal name



Funding Source

Organization

Ibaraki Hematology, Oncology & Palliation Expert Meeting(IB-HOPE)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 24 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2012 Year 03 Month 20 Day

Date of IRB

2013 Year 01 Month 25 Day

Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 01 Month 18 Day

Date trial data considered complete

2019 Year 01 Month 20 Day

Date analysis concluded

2019 Year 02 Month 06 Day


Other

Other related information



Management information

Registered date

2012 Year 11 Month 23 Day

Last modified on

2019 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010590


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name