Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; Daratumumab; Proteasome Inhibitors

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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