Daratumumab (HuMax-CD38) safety study in multiple myeloma – Open label, dose-escalation followed by open label, single-arm study

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2007-003783-22-SE
• Date of registration: 14/12/2007
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Daratumumab (HuMax-CD38) safety study in multiple myeloma – Open label, dose-escalation followed by open label, single-arm study
• Scientific title: Daratumumab (HuMax-CD38) safety study in multiple myeloma – Open label, dose-escalation followed by open label, single-arm study - Daratumumab HuMax-CD38 safety study in multiple myeloma
• Date of first enrolment: 03/03/2008
• Target sample size: 112
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003783-22
• 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: yes; Other trial design description: Open label dose escalation followed by open-label multiple cohort study, single dose; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Part 2: Same IMP, 2 different dose levels. Shedule E: Phase 3 IMP; Number of treatment arms in the trial: 1
• 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, Netherlands, Sweden, 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:
1. Documented diagnosis of multiple myeloma requiring systemic therapy
2. Age = 18 years.
3. ECOG performance status (0-2).
4. Life expectancy > 3 months.
5. Relapsed from or refractory to two or more different prior therapies
6. 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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion criteria:
1. Plasma cell leukemia defined as a plasma cell count > 2000/mm3.
2. Known amyloidosis
3. Patients who previously have received an allogenic stem cell transplant


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

Health Condition(s) or Problem(s) studied

Multiple myeloma
MedDRA version: 19.1 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 - Phase 1/2 Drug Product
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Daratumumab
CAS Number: 945721-28-8
Current Sponsor code: HuMax-CD38
Other descriptive name: HUMAX-CD38
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 24-

Product Name: Daratumumab
Product Code: HuMax-CD38 -Phase 3 Drug Product
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Daratumumab
CAS Number: 945721-28-8
Current Sponsor code: JNJ-54767414
Other descriptive name: HUMAX-CD38
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 16-

Primary Outcome(s)

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

Main Objective: To establish the safety profile of daratumumab when given as monotherapy in patients with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.

Secondary Objective: • To establish the pharmacokinetic profile of daratumumab after single and multiple infusions for both Phase 1/2 and Phase 3 drug products.
• To evaluate the efficacy of daratumumab when given as monotherapy in patients with multiple myeloma who are relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.
• To establish safe dose levels for future studies with daratumumab.
• To evaluation the immunogenicity of daratumumab.
• To optimize premedication and infusion parameters for daratumumab
• To evaluate biomarkers of daratumumab's mechanism of action, infusion reactions, and clinical response

Timepoint(s) of evaluation of this end point: 6 months after the Cycle 1 Day 1 dose of the last patient.
At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 6 months after the Cycle 1 Day 1 dose of the last patient.
At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed.

Secondary end point(s): - Pharmacokinetic parameters
- Objective response
- M-component
- Time to progression
- Duration of response
- Survival

Secondary ID(s)

2007-003783-22-DK

GEN501

Source(s) of Monetary Support

Janssen Research & Development, LLC