A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.

Key facts

Study ID

NCT02316106

Run by

Janssen Research & Development, LLC

People needed

123

Starts

2015-05-20

Expected to finish

2024-06-03

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
• Have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

You may not qualify if…

• Active multiple myeloma,requiring treatment as defined by the study protocol
• Primary systemic AL (immunoglobulin light chain) amyloidosis
• Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
• History of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
• Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
• Any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) 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

Where it is running

• Study site — Jacksonville, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Seattle, Washington, United States
• Study site — Box Hill, Australia
• Study site — Concord, Australia
• Study site — Melbourne, Australia
• Study site — Woodville South, Australia
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Brno, Czechia
• Study site — Hradec Králové, Czechia
• Study site — Prague, Czechia
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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