1. Home
  2. Approved trials
  3. » فارسی

Evalute and compare the effectiveness of oral thalidomide + Bortezomib (subcutaneous) + Dexamethasone(IV) regimen with Bortezomib (subcutaneous) + oral prednisolone + oral thalidomide regimen in patients with newly diagnosed multiple myeloma

Protocol summary

Summary
In this study to evaluate and compare the therapeutic effect Bortezomib subcutaneous + Dexamethasone (IV) + thalidomide oral with Bortezomib subcutaneous + oral prednisolone + thalidomide orally in patients with newly diagnosed multiple myeloma. In this study, which is done as a simple randomized clinical trial, 30 patients with newly diagnosed multiple myeloma who wish to participate in the study, and written informed consent form to complete, beginning with clinical trials including CBC-BUN-Cr-ESR-CRP-Ca-Alb-B2M-LDH-Electrophoresis of serum Pr and urine & BMA/B Divided into 2 groups: 1: 3 cycles of Bortezomib S.C (1.3 mg/m2 on days 1, 4, 8, and 11 at 3-week intervals Dexamethasone (40 mg I.V on days 1, 4, 8, and 11 at 3-week intervals) Tab Thalidomide (100 mg P.O Daily D1_D21) 2: 3 cycles of Bortezomib S.C (1.3 mg/m2 on days 1, 4, 8, and 11 at 3-week intervals) Tab Prednisolone (100 mg P.O on days 1_ 4, and 8_11 at 3-week intervals) Tab Thalidomide (100 mg P.O Daily D1_ D21) After 4 cycles of treatment to assess response to treatment clinical trials and once again BMA / B and flow cytometry repeated. In addition, the side effects of therapy in the two study groups was determined and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017032633143N1
Registration date: 2017-09-17, 1396/06/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
Mohmadamir Sarabi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 1382
Email address
msarabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pay personal expenses
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2018-03-18, 1396/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalute and compare the effectiveness of oral thalidomide + Bortezomib (subcutaneous) + Dexamethasone(IV) regimen with Bortezomib (subcutaneous) + oral prednisolone + oral thalidomide regimen in patients with newly diagnosed multiple myeloma
Public title
Effectiveness of prednisolone in treatment of multiple myeloma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Newly diagnosed patients with multiple myeloma who have over 18 years of age and are willing to participate in this study. Exclusion criteria: HIV-positive patients, patients with a history of malignant, uncontrolled diabetes, neuropathy grade 2 diabetes, significant liver and kidney and heart failure are excluded.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Poursina St, North Side of Tehran University, School of Medicine
City
Tehran
Postal code
1417613151
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1972

Health conditions studied

1

Description of health condition studied
multiple myeloma
ICD-10 code
C90.0
ICD-10 code description
Multiple myeloma

Primary outcomes

1

Description
Effectiveness
Timepoint
After 4 courses of treatment
Method of measurement
Check list and interviews

2

Description
side effects
Timepoint
After 4 courses of treatment
Method of measurement
Check list and interviews

Secondary outcomes

1

Description
Plt changes
Timepoint
After 4 courses of treatment
Method of measurement
check list and interviews

2

Description
Neuropathy
Timepoint
After 4 courses of treatment
Method of measurement
check list and interviews

3

Description
The cost of treatment
Timepoint
After 4 courses of treatment
Method of measurement
check list and interviews

4

Description
WBC changes
Timepoint
After 4 courses of treatment
Method of measurement
check list and interviews

5

Description
The number of pack cell
Timepoint
After 4 courses of treatment
Method of measurement
check list and interviews

6

Description
Quality of Life
Timepoint
After 4 courses of treatment
Method of measurement
check list and interviews

Intervention groups

1

Description
Inervention group Tab prednisolone 100 mg on day 1 to 4th and day 8 to eleventh in the form of orally administered for 4 (21-day) cycles
Category
Treatment - Drugs

2

Description
Control group by intravenous dexamethasone 40 mg on days 1, 4, 8 and 11 administered for 4 (21-day) cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Mohamadamir Sarabi
Street address
Bagherkhan Street, Tohid Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Personal
Full name of responsible person
Mohamadamir Sarabi
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadamir Sarabi
Position
Resident of Hematology & Oncology
Other areas of specialty/work
Street address
No 30, 25th Street, Kordestan highway
City
Tehran
Postal code
1437695451
Phone
+98 21 8800 1382
Fax
Email
drsam_amir@yahoo.com; msarabi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadamir Sarabi
Position
Fellowship of Hematology and Oncology
Other areas of specialty/work
Street address
No 21, Damascus Street, Palestine Street, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8889 6694
Fax
Email
drsam_amir@yahoo.com; msarabi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadamir Sarabi
Position
Fellowship of Hematology and Oncology
Other areas of specialty/work
Street address
No 30, 25 th ave, kordestan highway
City
Tehran
Postal code
Phone
+98 21 8800 1382
Fax
Email
drsam_amir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...