Multiple Myeloma Clinical Trial
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Summary
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Full Description
This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicenter study of daratumumab in participants diagnosed with intermediate or high-risk Smoldering Multiple Myeloma (SMM [ie, early disease without any symptoms]). Participants will be randomized (assigned by chance) to one of 3 treatment groups (arm A [long intense], arm B [intermediate] and arm C [short intense]) to receive daratumumab. Each treatment group will investigate 1 of 3 dosing schedules of daratumumab. The study will include a 28-Day Screening Phase, a Treatment Phase of 1 to 20 treatment cycles (each cycle is 8 weeks in duration for total period of 8 to 160 weeks), and a Follow up Phase of 4-weeks from the last dose of study drug. For participants in Arm A (long intense) and Arm B (intermediate), there is a possibility to extend treatment with IV daratumumab (Q8W) after the end of Cycle 20 if, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade >=3 treatment related toxicity, and at least stable disease has been achieved. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w). The Follow-up Phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. The end of the study will occur approximately 7 years after the last participant enrolled receives a first dose of study drug. 'Disease assessment will be performed locally per Standard of Care.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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There is 1 Location for this study
Little Rock Arkansas, , United States
Jacksonville Florida, , United States
West Palm Beach Florida, , United States
Atlanta Georgia, , United States
Boston Massachusetts, , United States
Ann Arbor Michigan, , United States
Saint Louis Missouri, , United States
Hackensack New Jersey, , United States
New York New York, , United States
Chapel Hill North Carolina, , United States
Cincinnati Ohio, , United States
Columbus Ohio, , United States
Philadelphia Pennsylvania, , United States
Nashville Tennessee, , United States
Seattle Washington, , United States
Box Hill , , Australia
Concord , , Australia
Melbourne , , Australia
Woodville South , , Australia
Calgary Alberta, , Canada
Edmonton Alberta, , Canada
Toronto Ontario, , Canada
Brno , , Czechia
Hradec Kralove , , Czechia
Praha 2 , , Czechia
Lille , , France
Nantes , , France
Paris , , France
Pierre Benite , , France
Rennes Cedex , , France
Berlin , , Germany
Chemnitz , , Germany
Essen , , Germany
Heidelberg , , Germany
Mainz , , Germany
München , , Germany
Tuebingen , , Germany
Würzburg , , Germany
Haifa , , Israel
Jerusalem , , Israel
Petah Tikva , , Israel
Tel Aviv , , Israel
Amsterdam , , Netherlands
Rotterdam , , Netherlands
Utrecht , , Netherlands
Nizhny Novgorod , , Russian Federation
Petrozavodsk , , Russian Federation
Ryazan , , Russian Federation
St-Petersburg , , Russian Federation
Ankara , , Turkey
Antalya , , Turkey
Izmir , , Turkey
Samsun , , Turkey
Cardiff , , United Kingdom
Nottingham , , United Kingdom
Southampton , , United Kingdom
Surrey , , United Kingdom
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