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

Withdrawn

Conditions: Kahler's Disease
Malignant growth of plasma cells
10035227

Registration Number: NL-OMON37444

Lead Sponsor: Genmab

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 4

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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary variable for this trial will be the incidence of AEs</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary variables are:<br /><br>* The rate of response according to the International Uniform Response<br /><br>Criteria21<br /><br>* PK variables (AUC, Cmax, minimum or trough concentration in plasma [Cmin],<br /><br>time to Cmax [Tmax], apparent clearance [CL], volume of distribution [V], and<br /><br>t1/2)<br /><br>* Time to progression<br /><br>* Duration of response<br /><br>* Progression-free survival</p><br>