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

Phase 1

• Conditions: Relapsed or Relapsed and Refractory Multiple myeloma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2011-005692-16-NL
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-16
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone<br>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<br>with relapsed or refractory MM<br>• To evaluate the pharmacokinetic (PK) profile of daratumumab when given in combination with bortezomib and<br>dexamethasone in subjects with relapsed or refractory MM;Primary end point(s): Adverse events (AE);Timepoint(s) of evaluation of this end point: At end of trial and as part of preparations for subsequent trials,<br>exploratory analysis of subsets of data may be performed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Pharmacokinetic parameters<br>- The rate of response according to the International Uniform<br>Response Criteria.<br>- M-component<br>- Time to progression<br>- Duration of response<br>- Progression free survival.;Timepoint(s) of evaluation of this end point: At end of trial and as part of preparations for subsequent trials,<br>exploratory analysis of subsets of data may be performed.