Daratumumab Study in Advanced Multiple Myeloma

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2013-000752-18-BE
• Date of registration: 30/07/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Daratumumab Study in Advanced Multiple Myeloma
• Scientific title: An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or are Double Refractory to a Proteasome Inhibitor and an IMiD
• Date of first enrolment: 04/11/2013
• Target sample size: 110
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000752-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Spain, 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:
Principal Inclusion Criteria in Lay Language (for a complete list of
inclusion criteria refer to the protocol):

- Documented multiple myeloma according to protocol-defined criteria
- Evidence of disease progression based on International Myeloma Working Group criteria
- Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
- Laboratory values and electrocardiogram within protocol-defined parameters at screening
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 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion criteria:
Principal Exclusion Criteria in Lay Language (for a complete list of
exclusion criteria refer to the protocol):

- Received daratumumab or other anti-CD38 therapies previously
- Nonsecretory multiple myeloma
- Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
- Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years
- Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C
- Has plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis


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

Health Condition(s) or Problem(s) studied

Multiple myeloma
MedDRA version: 16.0 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: JNJ-54767414 (Daratumumab)
Other descriptive name: HUMAX-CD38
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: The primary objective is to determine the efficacy of 2 treatment regimens of daratumumab, as measured by the overall response rate (ORR) (complete response [CR] + partial response [PR]),
in subjects with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD.

Secondary Objective: ? To assess the safety and tolerability of daratumumab.
? To assess the pharmacokinetics of drug product.
? To evaluate duration of and time to response to daratumumab.
? To determine the clinical benefit (CR+PR+MR) rate following treatment with daratumumab.
? To evaluate clinical outcomes including time to disease progression (TTP), PFS, and OS.
? To assess the pharmacokinetics, pharmacodynamics, and generation of antibodies to daratumumab (immunogenicity).
? To explore biomarkers predictive of response to daratumumab.

Primary end point(s): Overall response rate

Timepoint(s) of evaluation of this end point: Up to 6 months after the last participant is enrolled in the study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For a full list of timepoint(s) of evaluation of secondary endpoint refer to protocol:-

1. Up to 30 days after the last dose of study medication
2. From the date of initial documentation of a response (complete
or partial response) to the date of first documented evidence
of progressive disease as defined by International Myeloma
Working Group criteria
3. From the date of the first dose of daratumumab administered
to the date of the participant’s death
4. Up to 8 weeks after the last dose of daratumumab
administered
5. From the first dose of daratumumab administered and the first
efficacy evaluation that the participant has met all criteria for
complete or partial response

Secondary end point(s): For a full list of secondary end point refer to protocol:-

1. Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
2. Duration of response
3. Overall survival
4. Clinical benefit rate
5. Time to response

Secondary ID(s)

54767414MMY2002

Source(s) of Monetary Support

Janssen Research & Development, LLC