Early Access Treatment with Daratumumab for (Relapsed or Refractory) Multiple Myeloma
- Conditions
- Multiple myelomaTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
- Registration Number
- EUCTR2015-002993-19-GB
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 692
- Subject must be at least 18 years of age
- Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria:
Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal
to [>=] 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months)
OR
Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For
subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1,or 2
- A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
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 1060
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 940
- Ever enrolled in another daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab
- Subject receives any other anti-myeloma therapy while receiving daratumumab
- Enrolled in another interventional clinical study with therapeutic intent
- Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
- Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
- Prior exposure to any anti-CD38 monoclonal antibody
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to provide early access to daratumumab treatment and collect additional<br>safety data while the medication is not commercially available for subjects with multiple myeloma who<br>have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an<br>immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.;Secondary Objective: There is no hypothesis associated with this objective.;Primary end point(s): Safety;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable