Expired Study
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Boston, Massachusetts


Purpose:

Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.


Study summary:

This study is conducted in two parts. In part I, participants are enrolled into cohorts at increasing dose levels. Participant safety and efficacy during part I will determine the doses used for Part II. In part II participants will be enrolled into one of two sequential treatment arms using two of the doses defined in part 1 of the study. Part II was 5 cohorts, 3 with 8 milligram per kilogram (mg/kg) and 2 with 16 mg/kg. Part I and all but the last cohort in Part II were dosed with Phase 1/ 2 drug product. The last cohort in Part II was dosed with Phase 3 drug product. Both Part I and Part II are open-label/unmasked.


Criteria:

Inclusion criteria - Diagnosis of multiple myeloma (MM) requiring systemic therapy - Age greater than or equal to (>=) 18 years - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Life expectancy greater than (>) 3 months - Relapsed from or refractory to two or more different prior therapies - Signed Informed consent Exclusion criteria - Plasma cell leukemia defined as a plasma cell count > 2000/millimeter^3 (mm^3) - Known amyloidosis - Participants who previously have received an allogeneic stem cell transplant - Sensory or motor neuropathy of >= grade 3 - Past or current malignancy - Chronic or ongoing active infectious disease - Clinically significant cardiac disease - Significant concurrent, uncontrolled medical condition including, but not limited to, renal (except related to MM), hepatic, hematological except MM, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease - A baseline QT interval as corrected by Fridericia's formula > 470 millisecond (msec) for female participants or > 450 msec for male participants or a complete left bundle branch block (defined as a QRS interval >= 120 msec in left bundle branch block form) - Hypokalemia - Clinical signs of meningeal involvement of MM - Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume in 1 second (FEV1) less than (<) 60 percentage (%) of expected - History of significant cerebrovascular disease - Known Human Immunodeficiency Virus seropositivity - Positive serology for hepatitis B - Screening laboratory values - Concomitant corticosteroid - Other chemotherapy that is or may be active against myeloma within 3 weeks prior to Visit 2 (Part 1) or the first dose of daratumumab (Part 2). However, corticosteroid for myeloma (less than a 4-day course) could be administered within 1 week before Visit 2 (Part 1) or the first dose of daratumumab (Part 2) - Known hypersensitivity to components of the investigational product or severe allergic or anaphylactic reactions to humanized products - Participants who have received treatment with any nonmarket drug substance within 4 weeks before the first dose of daratumumab - Current participation in any other interventional clinical trial - Participants known or suspected of not being able to comply with a trial protocol (example, due to alcoholism, drug dependency, or psychological disorder) - Breastfeeding women or women with a positive pregnancy test at Screening - Women of childbearing potential not willing to use adequate contraception, defined as hormonal birth control or intrauterine device, during the trial and for 1 year after the last dose of daratumumab. For participants in the United States, the use of a double-barrier method is also considered adequate


NCT ID:

NCT00574288


Primary Contact:

Study Director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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