Back to Results

Phase I Daratumumab

Title Multiple Myeloma - An Open-label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax® CD38) (Anti-CD38 Monoclonal Antibody) in Combination with Backbone Regimens for Subjects with Multiple Myeloma
Therapeutic Area Multiple Myeloma
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender both
Contact George Mensing
More Information


The purpose of this research study is to assess the safety, tolerability and dosing of daratumumab when given to subjects with multiple myeloma in combination with various backbone treatment regimens: Velcade-dexamethasone (VD), Pomalidomide-dexamethasone (Pom-dex). Other purposes of this study are to find out how long daratumumab when combined with the backbone treatments stays in and acts on the body (this is shown by laboratory blood and urine tests) and how your body responds to daratumumab given with backbone.

Study Details

Inclusion Criteria

  • Previously received daratumumab or other anti-CD38 therapies
  • Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
  • Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years

Exclusion Criteria

  • Confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease
  • Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
  • Pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase

Study Requirements

There are two groups in this study for our site, either the Velcade-dexamethasone (VD) or Pomalidomie-dexamethasone (Pom-dex). Participants will remain in this study until it ends which is estimated to be 15 months after the last subject in this trial receives the first dose of Daratumumab. During this time, participants will continue to take the study drug for a maximum of 54 weeks. They will have physical exams, blood work, ECGs, and other tests/exams as per protocol.