NCT01998971CompletedPhase 1
A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma
An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (actual)
- First submitted
- 25 Nov 2013
- Start date
- 18 Feb 2014
- Primary completion date
- 31 Jan 2019
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT01998971
- EudraCT number
- 2013-003491-12
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 240
- From 18 Feb 2014 to the primary completion date, 31 Jan 2019
- 22 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received daratumumab or other anti-CD38 therapies
- Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
- Any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Other illness
- Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years
- Seropositive for human immunodeficiency virus, hepatitis B, or hepatitis C
- Clinically significant cardiac disease
- Plasma cell leukemia or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome
Other
- Peripheral neuropathy or neuropathic pain Grade 2 or higher
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
Who the study is looking for
- Confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease
- For carfilzomib-lenalidomide-dexamethasone (KRd) regimen: newly diagnosed myeloma. For carfilzomib-dexamethasone (CFZ-dex) regimen: relapsed or refractory 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.