Clinical Trial: DTPACE followed by Tandem Transplant with MEL 200 versus MEL/DTPACE Hybrid and DTPACE Consolidation

This study is no longer recruiting patients.

Sponsors and Collaborators: University of Arkansas
Celgene Corporation
Information provided by: University of Arkansas

Purpose

The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone.

Condition Treatment or Intervention Phase
Multiple Myeloma
 Drug: Cisplatin
 Drug: Cyclophosphamide
 Drug: Dexamethasone
 Drug: Doxorubicin
 Drug: Etoposide
 Drug: Sargramostim
 Drug: Melphalan
 Drug: Thalidomide
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: UARK 2001-12, A Phase III Study of DTPACE followed by Tandem Transplant with MEL 200 versus MEL/DTPACE Hybrid and DTPACE Consolidation in Patients with Active Multiple Myeloma

Further Study Details: 

Expected Total Enrollment:  540

Study start: June 2001

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Patients must have active multiple myeloma requiring treatment.
  • Patients that have received >450 mg/m2 of prior Adriamycin therapy are eligible, however, Adriamycin will be deleted from the DT PACE regimen in these patients, unless the left ventricular ejection fraction is > 55% on MUGA Scan or ECHO. If the patient has had > 450 mg/m2 of prior adriamycin, the LVEF must be evaluated prior to every cycle of DT PACE and it must be > 55% for patient to continue to receive adriamycin.
  • All necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration.
  • Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
  • Patients must have a platelet count greater than or equal to 100,000/microliters. Patients with platelet count <100,000/microliters may be enrolled if it is felt to be due to extensive marrow plasmacytosis.
  • Patients must have a creatinine <3 mg/dl and a creatinine clearance greater than or equal to 30 ml/minute. Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin dose.
  • Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN and direct bilirubin < 2.0 mg/dl.
  • Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with some exception of: Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55% or patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. - Patients must not have received a prior autotransplant or allograft.
  • Patients with recent (less than or equal to 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO or must be greater than or equal to 50% 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.
  • Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease.
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval.
  • Pregnant or nursing women may not participate.
  • Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
  • Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies greater thanor equal to 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) greater than or equal to 50% of predicted. Patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.

Location Information


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

Study chairs or principal investigators

Guido J Tricot, M.D., Ph.D.,  Principal Investigator,  UAMS   

More Information

Myeloma Institute for Research & Therapy website

Study ID Numbers:  UARK 2001-12
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  June 3, 2004
ClinicalTrials.gov Identifier:  NCT00083915
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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