UARK 2003-41: A Study of High-Dose Density Therapy in Patients With Multiple Myeloma

September 1, 2011 updated by: University of Arkansas

UARK 2003-41: A Phase II Study of High-Dose Density Therapy With Tandem Autologous Transplants for Patients With Multiple Myeloma

The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past.

Study Overview

Status

Completed

Conditions

Multiple Myeloma

Intervention / Treatment

Procedure: High-Dose Density Therapy

Detailed Description

This study will evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.

Study Type

Interventional

Enrollment (Actual)

140

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with symptomatic multiple myeloma, previously treated or untreated.
Patients previously untreated must not be eligible for UARK 2003-33.
Karnofsky performance score > 60%, unless due to MM
Patients must be <75 years of age at the time of registration
Patient must not have had a prior auto- or allotransplant
Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.
Negative serology for HIV.
Baseline studies within 60 days prior to registration; patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.
Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible. Ejection fraction by ECHO or must be > 40% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated.

Exclusion Criteria:

Uncontrolled infection as defined in protocol section 5.1.11
Liver function abnormalities with total bilirubin more than twice the upper limit of normal or AST or ALT more than three times the upper limit of normal
Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of < 30ml/min
Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria
Platelet count < 100,000/mm3, or ANC < 1,000/μl
POEMS Syndrome
Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis
New York Hospital Association (NYHA) Class III or Class IV heart failure
Myocardial infarction within the last 6 months
Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias
Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy [β-HCG] test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each dose of study drug
Breast-feeding women may not participate
Prior adriamycin exposure >450 mg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls. Time Frame: seven months	seven months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the ability of pegfilgrastim to mobilize stem cells when administered following DTPACE in MM patients with active disease, compared to historical controls mobilized with DTPACE and either GM-CSF or G-CSF. Time Frame: annually	annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

Principal Investigator: Frits van Rhee, MD, PhD, UAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 10, 2005

First Submitted That Met QC Criteria