Clinical Trial: Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Single Autologous Transplant Followed by Consolidation and Maintenance for Participants ≥ 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy

Brief Summary: This phase II trial investigates whether patients greater than or equal to 65 years of age diagnosed with myeloma or another plasma cell malignancy will have better outcomes with transplant followed by maintenance therapy, as primarily measured by progression-free survival, versus non-transplant approaches.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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 o
Sponsor: University of Iowa

Current Primary Outcome:

• PFS [ Time Frame: From the start of DPACE for all participants who have had at least one day of protocol treatment, assessed up to 4 years ]
  Estimated with the method of Kaplan-Meier and modeled as functions of clinicopathological factors with Cox regression.
• Severe complications (ICU admission, death), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: Up to 4 years ]
  Frequencies of toxicities will be tabulated on all participants who have completed at least one day of induction therapy. Toxicities will be compared descriptively to historical controls.
• Percentage of participants able to complete full course of therapy [ Time Frame: Up to 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Complete response (CR) rate using the International Myeloma Working group uniform response criteria [ Time Frame: Up to 4 years ]
  Summarized with binomial proportions.
• Event free survival [ Time Frame: Time from initial study enrollment to progression/relapse of disease or death from any cause, assessed up to 4 years ]
• Time to progression [ Time Frame: Up to 7 years ]
  Estimated with the method of Kaplan-Meier and modeled as functions of clinicopathological factors with Cox regression.
• Overall survival [ Time Frame: Time from initial study enrollment to death from any cause, assessed up to 4 years ]

Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: May 6, 2013
Date Started: April 2013
Date Completion: December 2017
Last Updated: February 20, 2017
Last Verified: February 2017