Multiple Myeloma Clinical Trial

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


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

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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.

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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

Study is for people with:

Multiple Myeloma


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:

Active, not recruiting


Janssen Research & Development, LLC

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There is 1 Location for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma


Phase 2

Estimated Enrollment:


Study ID:


Recruitment Status:

Active, not recruiting


Janssen Research & Development, LLC

How clear is this clinincal trial information?


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