Single Autologous Transplant Followed by Consolidation and Maintenance for Participants ≥ 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy
I. To evaluate the progression-free survival (PFS) from the start of dexamethasone,
cisplatin, Adriamycin (doxorubicin),Cytoxan (cyclophosphamide), etoposide (DPACE) for all
participants who have had at least one day of protocol treatment.
II. To evaluate how well such therapy is tolerated in patients mainly over the age of 65
years by assessing severe complications (intensive care unit [ICU] admission, death) and the
percentage of participants able to complete the full course of therapy.
I. To evaluate Quality-Of-Life post-transplant using the European Organization for Research
and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30 and QLC-MY20.
INDUCTION THERAPY: Patients receive dexamethasone orally (PO) on days 1-4 and 8-11,
cisplatin intravenously (IV) continuously, doxorubicin hydrochloride IV continuously,
cyclophosphamide IV, and etoposide IV on days 1-4. Patients then receive pegfilgrastim
subcutaneously (SQ) on days 6 and 13 and undergo collection of stem cells when white blood
cell (WBC) and cluster of differentiation (CD)34 counts are within program range. Following
stem cell collection, patients may receive interim dexamethasone PO on days 1-4, every 14
days at the discretion of the treating physician.
TRANSPLANT: Beginning between 4 weeks to 6 months after the first day of induction therapy,
patients receive as transplant conditioning regimen dexamethasone PO on days -4 to -1 and
days +2 through +5, bortezomib IV bolus on days -4, -1, 2, and 5, thalidomide PO on days -4
to 5, and melphalan IV on days -4 and -1. Patients undergo autologous peripheral blood stem
cell transplant (PBSCT) on day 0. Between transplant and consolidation therapy, patients
receive dexamethasone PO on days 1-4 every 21 days and thalidomide PO daily.
CONSOLIDATION THERAPY: Beginning 2-3 months post-transplant, patients with platelet counts >
80,000/ul receive dexamethasone PO on days 1-4 and 8-11, thalidomide PO on days 1-11,
bortezomib IV on days 1, 4, 8, and 11, cisplatin IV continuously, doxorubicin hydrochloride
IV continuously, cyclophosphamide IV continuously, and etoposide IV continuously on days
1-4. Treatment continues in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY YEAR 1: Beginning 6 weeks-3 months after consolidation therapy or 4
weeks to 3 months after transplant if consolidation is skipped, patients receive bortezomib
IV bolus on days 1, 4, 15, and 18, thalidomide PO QD on days 1-28 or lenalidomide PO once
daily (QD) on days 1-21, and dexamethasone PO on days 1-4 and 15-18. Treatment repeats every
28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY YEAR 2: Patients receive bortezomib IV on days 1, 4, 15, and 18,
cyclophosphamide PO or IV on days 1 and 15, and dexamethasone PO QD on days 1, 8, 15, and
22. Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least once annually.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimated with the method of Kaplan-Meier and modeled as functions of clinicopathological factors with Cox regression.
From the start of DPACE for all participants who have had at least one day of protocol treatment, assessed up to 4 years
University of Iowa
United States: Federal Government
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|