ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	21 August 2017
Main ID:	EUCTR2005-001628-35-BE
Date of registration:	13/12/2005
Prospective Registration:	Yes
Primary sponsor:	EBMT - CLWP
Public title:	A randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation - MMVAR
Scientific title:	A randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation - MMVAR
Date of first enrolment:	31/01/2006
Target sample size:	452
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001628-35
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Austria	Belgium	Czech Republic	Germany	Hungary	United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
-histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
-relapsing or having a progressive disease at least one year after an autologous transplantation
-karnofsky index more than 50%
-post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
-written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-patient with non-secretory MM
-Creat clearance lower than 30 ml/min, platelets lower then 40000, ANC lower than 1000
-peripheral neuropathy of grade 2 or more within 14 days before enrollment
-HIV, hepatitis A,B,C positive
-female subject pregnant or breast-feeding

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

multiple myeloma patients in progression or relapse after autologous transplantation

Intervention(s)

Product Name: Velcade
Product Code: PS341
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Bortezomib
CAS Number: 179324-69-7
Other descriptive name: Bortezomib,PS341,MLN341,LDP341
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.5-

Product Name: Thalidomide
Pharmaceutical Form: Capsule*
INN or Proposed INN: Thalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Dexamethasone
Pharmaceutical Form: Capsule*
INN or Proposed INN: Dexamethasone
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective: to compare the treatment groups for :
- response rate (complete + partial + minimal) using standard criteria
-overall survival
- side effects

Main Objective: test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation

Primary end point(s): Time to Progression

Secondary Outcome(s)

Secondary ID(s)

X05140

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.