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

PHASE2CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

May 20, 2015

Primary Completion Date

June 2, 2023

Study Completion Date

June 3, 2024

Conditions
Multiple Myeloma
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.

Trial Locations (57)

Unknown

Little Rock

Jacksonville

West Palm Beach

Atlanta

Boston

Ann Arbor

St Louis

Hackensack

New York

Chapel Hill

Cincinnati

Columbus

Philadelphia

Nashville

Seattle

Box Hill

Concord

Melbourne

Woodville South

Calgary

Edmonton

Toronto

Brno

Hradec Králové

Prague

Lille

Nantes

Paris

Pierre-Bénite

Rennes

Berlin

Chemnitz

Essen

Heidelberg

Mainz

München

Tübingen

Würzburg

Haifa

Jerusalem

Petah Tikva

Tel Aviv

Amsterdam

Rotterdam

Utrecht

Nizhny Novgorod

Petrozavodsk

Ryazan

Saint Petersburg

Ankara

Antalya

Izmir

Samsun

Cardiff

Nottingham

Southampton

Surrey

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02316106 - A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma | Biotech Hunter | Biotech Hunter