UMIN-CTR Clinical Trial

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

Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

KT-MM

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

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

Date of disclosure of the study information

2012

Year

11

Month

24

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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