UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide

Summary

Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.

Conditions

• Multiple Myeloma

Interventions

DRUG

Interim/Maintenance Dexamethasone

20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance

DRUG

Induction/Consolidation Dexamethasone

40 mg Days 1-4

DRUG

Induction/Consolidation Cisplatin

10 mg/m2 by continuous infusion Days 1-4

DRUG

Induction/Consolidation Adriamycin

10 mg/m2 by continuous infusion Days 1-4

DRUG

InductionConsolidation Cyclophosphamide

400 mg/m2 by continuous infusion Days 1-4

DRUG

Induction/Consolidation Etoposide

40 mg/m2 by continuous infusion Days 1-4

DRUG

Induction Pegfilgrastim

6 mg Days 6 and 13

DRUG

Transplant 1 Dexamethasone

20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7

DRUG

Transplant 1 Cisplatin

20 mg/m2 by continuous infusion Days -3 and -2

DRUG

Transplant 1 Adriamycin

20 mg/m2 by continuous infusion Days -3 and -2

DRUG

Transplant 1 Cyclophosphamide

800 mg/m2 by continuous infusion Days -3 and -2

DRUG

Transplant 1 Etoposide

80 mg/m2 by continuous infusion Days -3 and -2

DRUG

Transplant 1 Melphalan

50 mg/m2 Days -2 and -1

DRUG

Transplant 1 and 2 Pegfilgrastim

6 mg Day +6

PROCEDURE

Autologous Peripheral Blood Stem Cell Transplant (ASCT)

Day 0

DRUG

Transplant 2 Carmustine

300 mg/m2 Day -5

DRUG

Transplant 2 Etoposide

200 mg/m2 Days -5, -4, -3, -2

DRUG

Transplant 2 Cytarabine

400 mg/m2 Days -5, -4, -3, -2

DRUG

Transplant 2 Melphalan

140 mg/m2 Day -1

DRUG

Transplant 2 Dexamethasone

20 mg Days -5, -4, -3, -2, +4, +5, +6, +7

DRUG

Transplant 1 and 2 Bortezomib

1 mg/m2 Days -4, -1, +3, +7

DRUG

Transplant 1 and 2 Thalidomide

200 mg Days -4 to +5

Sponsors & Collaborators

• University of Arkansas

  lead OTHER

Principal Investigators

• Frits van Rhee, MD, PhD · University of Arkansas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States

Study Locations