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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

seven months

Safety Issue:

No

Principal Investigator

Frits Van Rhee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Institutional Review Board

Study ID:

UARK 2003-41

NCT ID:

NCT00113932

Start Date:

December 2003

Completion Date:

July 2010

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205