2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT03004287
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carfilzomib — DRUG
    Given by vein: days 1 and 2 of Induction; days 1, 8, 15, and 22 of Consolidation 1; and days 1, 8, 15, and 22 of alternating 3-month blocks during Maintenance.
  • Thalidomide — DRUG
    Given by mouth at bedtime: days 1-4 of Induction
  • Dexamethasone — DRUG
    Given by mouth or by vein: days 1-4 of Induction; days -4 - -1 of Transplant(s); and days 1, 8, 15, and 22 of every cycle during Maintenance
  • Daratumumab — DRUG
    Given by vein: day -1 of induction; days 1 and 8 of Immunological Consolidations; and day 1 of each Maintenance cycle
  • Cisplatin — DRUG
    Given by vein: days 1-4 (continuous infusion) of Induction
  • Adriamycin — DRUG
    Given by vein: days 1-4 (continuous infusion) of Induction
  • Cyclophosphamide — DRUG
    Given by vein: days 1-4 (continuous infusion) of Induction
  • Etoposide — DRUG
    Given by vein: days 1-4 (continuous infusion) of Induction
  • Melphalan — DRUG
    Given by vein: days -4 - -1 of Transplant(s)
  • ASCT — PROCEDURE
    day 0 of Transplant(s)
  • Lenalidomide — DRUG
    Given by mouth: days 1-21 of alternating 3-month blocks during Maintenance
  • Bortezomib — DRUG
    Given by vein or subcutaneous injection: may be substituted for carfilzomib throughout the study regimen at the discretion of the treating physician

Study Details

This study will assess whether adding one of the newest multiple myeloma therapies, daratumumab, into the Total Therapy approach helps patients live longer with fewer side effects

Key Dates

Start date
Jul 1, 2017
Status verified
Sep 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment
    Induction Chemotherapy: Carfilzomib, Thalidomide, Dexamethasone, Daratumumab , CisPlatin, Adriamycin, Cyclophosphamide and Etoposide (KTD-Dara-PACE). Autologous Stem Cell Transplant (ASCT) 1: Melphalan, Dexamethasone, ASCT. Immunological Consolidation 1: Daratumumab. Consolidation 1: Daratumumab, Carfilzomib, Dexamethasone (Dara-KD). ASCT 2 (optional): Melphalan, Dexamethasone, ASCT. Immunological Consolidation 2: Daratumumab. Maintenance: Dara-KD alternating with Daratumumab, lenalidomide, and Dexamethasone (Dara-RD) in 3-month blocks. Bortezomib may be substituted for carfilzomib throughout the regimen at the discretion of the treating physician.

Primary Outcome Measure

Measure the progression-free survival in patients with high risk multiple myeloma [ Time Frame: 48 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-

Find similar trials in Little Rock, AR

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Arkansas for Medical Sciences· Little Rock, AR

Related Studies