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COMPLETED
NCT02316106
PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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

Official title: A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2015-05-20

Completion Date

2024-06-03

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

DRUG

daratumumab

16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (\>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. 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).

DRUG

daratumumab

16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and every 8 weeks after Cycle 20. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (\>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. 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).

DRUG

daratumumab

16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length.

Locations (57)

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

St 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 Králové, Czechia

Prague, Czechia

Lille, France

Nantes, France

Paris, France

Pierre-Bénite, France

Rennes, France

Berlin, Germany

Chemnitz, Germany

Essen, Germany

Heidelberg, Germany

Mainz, Germany

München, Germany

Tübingen, Germany

Würzburg, Germany

Haifa, Israel

Jerusalem, Israel

Petah Tikva, Israel

Tel Aviv, Israel

Amsterdam, Netherlands

Rotterdam, Netherlands

Utrecht, Netherlands

Nizhny Novgorod, Russia

Petrozavodsk, Russia

Ryazan, Russia

Saint Petersburg, Russia

Ankara, Turkey (Türkiye)

Antalya, Turkey (Türkiye)

Izmir, Turkey (Türkiye)

Samsun, Turkey (Türkiye)

Cardiff, United Kingdom

Nottingham, United Kingdom

Southampton, United Kingdom

Surrey, United Kingdom