A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03301220
Phase
PHASE3
Status
Completed

Conditions

  • Smoldering Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab SC: daratumumab + rHuPH20 — DRUG
    Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 \[2000 U/mL\]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration.

Study Details

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

Key Dates

Start date
Nov 7, 2017
Status verified
Jun 2026
Primary completion
May 1, 2024
Completion
May 4, 2026

Study Design

Enrollment
390 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A: Active Monitoring
    Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.
  • Experimental: Arm B: Daratumumab SC
    Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) [ Time Frame: From randomization (Day -5) up to 77 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC - HALPhoenixArizona85016-
Innovative Clinical Research IncWhittierCalifornia90805-
Miami Cancer InstituteMiamiFlorida33176-
Emory UniversityAtlantaGeorgia30322-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
East Jefferson General HospitalMetairieLouisiana70006-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63110-
VA Southern Nevada HealthcareNorth Las VegasNevada89086-
New York Oncology HematologyAlbanyNew York12206-
Stony Brook University Medical CenterStony BrookNew York11794-
University of North CarolinaChapel HillNorth Carolina27599-
Levine Cancer Institute, Carolinas HealthCare SystemCharlotteNorth Carolina28204-
Cleveland ClinicClevelandOhio44195-
The Ohio State UniversityColumbusOhio43210-
OHSU/CHMPortlandOregon97239-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Texas Oncology P A 1AustinTexas78705-
VA North Texas Health Care SystemDallasTexas75216-
Texas Oncology P ATylerTexas75702-
University of WashingtonSeattleWashington90805-

Find similar trials in Phoenix, AZ

By research site
Arizona Oncology Associates, PC - HAL· Phoenix, AZInnovative Clinical Research Inc· Whittier, CAMiami Cancer Institute· Miami, FLEmory University· Atlanta, GAUniversity of Iowa Hospitals and Clinics· Iowa City, IAEast Jefferson General Hospital· Metairie, LA

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