Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02477891
Status
Approved For Marketing

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion on Day 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Day 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until documented progression, unacceptable toxicity, or study end. Each cycle is of 28 days.

Study Details

The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.

Key Dates

Status verified
Jan 2019

Locations (41)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-Little RockArkansas--
-DuarteCalifornia--
-Fountain ValleyCalifornia--
-GilroyCalifornia--
-GreenbraeCalifornia--
-Los AngelesCalifornia--
-West HollywoodCalifornia--
-DenverColorado--
-New HavenConnecticut--
-JacksonvilleFlorida--
-OcalaFlorida--
-West Palm BeachFlorida--
-AtlantaGeorgia--
-BoiseIdaho--
-ChicagoIllinois--
-IndianapolisIndiana--
-Iowa CityIowa--
-TopekaKansas--
-LouisvilleKentucky--
-BaltimoreMaryland--
-BethesdaMaryland--
-BostonMassachusetts--
-DetroitMichigan--
-St LouisMissouri--
-Great FallsMontana--
-OmahaNebraska--
-FlemingtonNew Jersey--
-HackensackNew Jersey--
-New BrunswickNew Jersey--
-BuffaloNew York--
-New YorkNew York--
-Chapel HillNorth Carolina--
-CharlotteNorth Carolina--
-CorvallisOregon--
-HersheyPennsylvania--
-CharlestonSouth Carolina--
-GreenvilleSouth Carolina--
-DallasTexas--
-HoustonTexas--
-FairfaxVirginia--

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