A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01998971
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.
  • Velcade — DRUG
    Administered subcutaneously in accordance with product labeling and local standards.
  • Pomalidomide — DRUG
    Administered orally in accordance with product labeling and local standards.
  • Dexamethasone — DRUG
    Administered intravenously or orally in accordance with product labeling and local standards.
  • Melphalan — DRUG
    Administered orally in accordance with product labeling and local standards.
  • Prednisone — DRUG
    Administered intravenously or orally in accordance with product labeling and local standards.
  • Thalidomide — DRUG
    Administered orally in accordance with product labeling and local standards.
  • Diphenhydramine — DRUG
    Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
  • Acetaminophen — DRUG
    Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
  • Carfilzomib — DRUG
    Administered intravenously in accordance with product labeling and local standards.
  • Lenalidomide — DRUG
    Administered orally in accordance with product labeling and local standards.
  • Montelukast — DRUG
    Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.

Study Details

The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.

Key Dates

Start date
Feb 18, 2014
Status verified
Apr 2025
Primary completion
Jan 31, 2019
Completion
Jan 11, 2024

Study Design

Enrollment
240 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab + VD
    Daratumumab will be administered with Velcade-dexamethasone (VD).
  • Experimental: Daratumumab + VMP
    Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).
  • Experimental: Daratumumab + VTD
    Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
  • Experimental: Daratumumab + Pom-dex
    Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
  • Experimental: Daratumumab + CFZ-dex
    Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
  • Experimental: Daratumumab + KRd
    Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.

Primary Outcome Measure

Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) [ Time Frame: Up to 30 days after the last dose of study medication ]

Locations (10)

FacilityCityStateZIPSite coordinators
-DuarteCalifornia--
-AtlantaGeorgia--
-ChicagoIllinois--
-IndianapolisIndiana--
-BostonMassachusetts--
-New YorkNew York--
-RochesterNew York--
-CharlotteNorth Carolina--
-PhiladelphiaPennsylvania--
-DallasTexas--

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
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