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

Phase 1

• Conditions: Relapsed or Relapsed and Refractory Multiple myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005709-62-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: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Before entering Phase 1 of the study, subjects must:
1. Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with Len/Dex.
2. Have measurable levels of M component, defined as serum M component= 1.0 g/dL and/or urine M component = 200 mg/24 hour sample.
3. Be = 18 years of age.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
5. Have a life expectancy of = 3 months.
6. Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed.

Before entering Phase 2 of the study, subjects must:
1. - Have received at least 1 prior line of therapy for multiple myeloma
- Have achieved a response (PR or better) to at least one prior regimen.
- Have documented evidence of progressive disease (PD) as defined by the IMWG criteria on or after their last regimen.
2. Have measurable levels of M component, defined as serum M component = 1.0 g/dL and/or urine M component = 200 mg/24 hour sample.
3. Be = 18 years of age.
4. Have an ECOG performance status score of 0, 1, or 2
5. Have a life expectancy of = 3 months.
6. Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Have previously received an allogenic stem cell transplant.
2. Have received auto SCT within 12 weeks before the first infusion.
3. Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion.
4.Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide.
Refractory to lenalidomide is defined as either:
- Subjects whose disease progresses within 60 days of lenalidomide, or
- Subjects whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an MR or development of PD while on lenalidomide.

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 Len/Dex in subjects with relapsed or relapsed and refractory multiple myeloma;Secondary Objective: • To evaluate the efficacy of daratumumab when given in combination with Len/Dex in subjects with relapsed or relapsed and refractory multiple myeloma<br>• To evaluate the PK profile of daratumumab when given in combination with Len/Dex in subjects with relapsed or relapsed and refractory multiple myeloma<br>• To assess the immunogenicity of daratumumab;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): - The rate of response<br>- Pharmacokinetic parameters<br>- Time to progression<br>- Duration of response- 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.