Daratumumab Open label, dose-escalation safety study in Combination with Bortezomib and Dexamethasone in Patients with multiple myeloma

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2011-005692-16-NL
• Date of registration: 16/02/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Daratumumab Open label, dose-escalation safety study in Combination with Bortezomib and Dexamethasone in Patients with multiple myeloma
• Scientific title: 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: 01/08/2012
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005692-16
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark, France, Italy, Netherlands, United Kingdom, United States

Contacts

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion criteria

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 Mcomponent 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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

Health Condition(s) or Problem(s) studied

Relapsed or Relapsed and Refractory Multiple myeloma
MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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-

Primary Outcome(s)

Main Objective: To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone
in subjects with relapsed or refractory MM

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

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.

Primary end point(s): Adverse events (AE)

Secondary Outcome(s)

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.

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.

Secondary ID(s)

GEN504

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 01/08/2012
Contact: