Main
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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:
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EUCTR |
Last refreshed on:
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8 April 2013 |
Main ID: |
EUCTR2011-005692-16-DK |
Date of registration:
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28/03/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Daratumumab Open label, dose-escalation safety study in Combination
with Bortezomib and Dexamethasone in Patients with multiple myeloma
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Scientific title:
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An Open-label, International, Multicenter, Dose Escalating
Phase I/II Trial Investigating the Safety of Daratumumab in
Combination with Bortezomib and Dexamethasone in
Patients with Relapsed or Refractory Multiple Myeloma - Daratumumab in combination with bortezomib and dexamethasone |
Date of first enrolment:
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27/03/2012 |
Target sample size:
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40 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005692-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: no
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
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Denmark
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France
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Italy
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial information
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Address:
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Bredgade 34,
1260
Copenhagen K
Denmark |
Telephone:
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+4570202728 |
Email:
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Regulatory@genmab.com |
Affiliation:
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Genmab A/S |
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Name:
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Clinical Trial information
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Address:
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Bredgade 34,
1260
Copenhagen K
Denmark |
Telephone:
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+4570202728 |
Email:
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Regulatory@genmab.com |
Affiliation:
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Genmab A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria: - (Part 1) Have relapsed MM after receiving a minimum of 2 and a
maximum of 4 prior lines of therapy and be eligible for treatment with Bor/Dex. Subjects must be naive to Bortezomib treatment
- (Part 2) Have relapsed MM after receiving a minimum of 1 and a
maximum of 3 prior lines of therapy, but not have MM that is refractory to the last treatment, and be eligible for treatment with Bor/Dex.
-Have measurable levels of M-component, defined as serum M-component 1.0 g/dL and/or urine M-component 200 mg/24-hour sample.
- Be older than or be 18 years of age.
- ECOG performance status (0-2).
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out. 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria: - Have previously received an allogenic stem cell transplant.
- Have received auto SCT within 12 weeks before the first infusion.
- Have received chemotherapy or any experimental drug or therapy
within 3 weeks before the first infusion.
- Have received bortezomib, lenalidomide, or thalidomide within 2 weeks before the first infusion.
- Have MM that is refractory to bortezomib, defined as not having a minimum clinical response of MR for at least 2 months during the last treatment with bortezomib).
- Must not be known to be seropositive for HIV
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Relapsed or Relapsed and Refractory Multiple myeloma MedDRA version: 14.1
Level: PT
Classification code 10028228
Term: Multiple myeloma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Name: Daratumumab Product Code: HuMax-CD38 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Daratumumab CAS Number: 945721-28-8 Current Sponsor code: Daratumumab Other descriptive name: HuMax-CD38 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed.
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Main Objective: To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
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Primary end point(s): Adverse events (AE)
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Secondary Objective: • To evaluate the efficacy of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM • To evaluate the pharmacokinetic (PK) profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
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Secondary Outcome(s)
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Secondary end point(s): - Pharmacokinetic parameters
- The rate of response according to the International Uniform
Response Criteria.
- M-component
- Time to progression
- Duration of response
- Progression free survival.
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Timepoint(s) of evaluation of this end point: At end of trial and as part of preparations for subsequent trials,
exploratory analysis of subsets of data may be performed.
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Secondary ID(s)
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2011-005692-16-NL
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GEN504
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Source(s) of Monetary Support
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Genmab A/S
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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