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Dexamethasone Liquid

Decadron Liquid; Hexadrol Liquid



Clinical Trial: Total Therapy II

This study is no longer recruiting patients.

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

Purpose

This study has been designed to evaluate whether “anti-angiogenesis” therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.

Condition Treatment or Intervention Phase
Multiple Myeloma
 Drug: Thalidomide
 Drug: Ara-C
 Drug: BCNU
 Drug: Cisplatin
 Drug: Cytoxan
 Drug: Dexamethasone
 Drug: Doxorubicin
 Drug: Etoposide
 Drug: Figrastim
 Drug: Recombinant GM-CSF
 Drug: Interferon-alpha-2b
 Drug: Melphalan
 Drug: Vincristine
Phase III

MedlinePlus related topics:  Multiple Myeloma

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

Official Title: UARK 98-026, Total Therapy II – A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis with Thalidomide and Post-Transplant Consolidation Chemotherapy

Further Study Details: 

Expected Total Enrollment:  673

Study start: August 1998

Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation, and maintenance. Induction is designed to induce (or bring about) myeloma into remission. Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide. Some patients may be eligible to receive the transplant as an outpatient, based on general health and other factors.After recovery from the transplant phase of the study (approximately 6 weeks), patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment. All patients will receive post-transplant consolidation treatment, which in earlier studies has been found to be helpful in maintaining patients response after transplant. Therefore, all patients will receive a combination of drugs called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide. If you are also taking thalidomide, you will continue taking it throughout, and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks, and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete, you will begin the last phase of the study, which is maintenance. Maintenance is designed to keep your myeloma in remission long-term.

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Patients must have newly diagnosed active multiple myeloma requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
  • Protein criteria must be present in order to evaluate response.Non-secretory patients are eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focal plasmacytomas on MRI or diffuse hyperintense signal on STIR images in the absence of hematopoietic growth factors is seen.
  • All necessary baseline studies for determining stage, bloodwork, and bone marrow must be obtained within 35 days prior to registration.
  • Patients must have received no more than one cycle of prior chemotherapy including one month of Dexamethasone and Thalidomide for this disease. Patients may have received prior radiotherapy provided approval has been obtained by one of the study coordinators.
  • 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 with renal failure, even if on dialysis, are eligible if it is felt to be due to myeloma and if the duration of renal failure does not exceed two months
  • Patients must be 75 years of age or less at the time of registration
  • 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.
  • If medically appropriate, patients with pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath should have these conditions attended to prior to registration.

Exclusion Criteria:

  • Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection
  • Patients must not have uncontrolled diabetes
  • Patients with recent (< or =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 MUGA should be within the institutional normal range and must be performed within 42 days prior to registration.
  • 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 and there must be no prior treatment with cytotoxic drugs that could potentially be assigned on this treatment protocol.
  • Pregnant or nursing women may not participate. Women of child-bearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method.

Location Information


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

Study chairs or principal investigators

Bart Barlogie, M.D., Ph.D.,  Principal Investigator,  UAMS   

More Information

Myeloma Institute for Research & Therapy website

Study ID Numbers:  UARK 98-026
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  May 25, 2004
ClinicalTrials.gov Identifier:  NCT00083551
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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November 18, 2008



Page Updated: June 1, 2005
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