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DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation
This study is ongoing, but not recruiting participants.
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083915
  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 Intervention Phase
Multiple Myeloma
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Etoposide
Drug: Sargramostim
Drug: Melphalan
Drug: Thalidomide
Drug: Erythropoietin
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Etoposide Cisplatin Melphalan Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Epoetin alfa Erythropoietin Thalidomide Sargramostim Granulocyte-macrophage colony-stimulating factor Etoposide phosphate Melphalan hydrochloride Sarcolysin
U.S. FDA Resources
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 as provided by University of Arkansas:

Primary Outcome Measures:
  • To find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. [ Time Frame: 3 years depending on start date ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: June 2001
Estimated Study Completion Date: June 2013
Arms Assigned Interventions
1: Active Comparator Drug: Dexamethasone
40mg PO -2 until +1 on Arm 1. 40mg PO -3 through 0 on Arm 2.
Drug: Sargramostim
divided in 2 doses of 10mcg/kg
Drug: Melphalan
200 mg/m2 IV over <20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
Drug: Erythropoietin
40,000 U subcutaneously every week starting on day +6 until Hemoglobin reaches 16g/dl.
2: Active Comparator Drug: Cisplatin
20mg/m2 continuous infusion days -3 and -2.
Drug: Cyclophosphamide
800 mg/m2 continuous infusion days -3 and -2.
Drug: Dexamethasone
40mg PO -2 until +1 on Arm 1. 40mg PO -3 through 0 on Arm 2.
Drug: Doxorubicin
20mg/m2 continuous infusion -3 and -2.
Drug: Etoposide
80mg/m2 continuous infusion -3 and -2.
Drug: Sargramostim
divided in 2 doses of 10mcg/kg
Drug: Melphalan
200 mg/m2 IV over <20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2.
Drug: Thalidomide
200mg PO Continuing to Day +5, then hold until platelets >50K.
Drug: Erythropoietin
40,000 U subcutaneously every week starting on day +6 until Hemoglobin reaches 16g/dl.

Detailed Description:

To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with D.T. PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of CR/near CR/VGPR rate and event-free and overall survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 than or 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083915

Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Guido J Tricot, M.D., Ph.D. UAMS
  More Information

Myeloma Institute for Research & Therapy website  This link exits the ClinicalTrials.gov site

Responsible Party: University_Of_Arkansas ( Edwina Mosby, CRA )
Study ID Numbers: UARK 2001-12
Study First Received: June 3, 2004
Last Updated: December 10, 2007
ClinicalTrials.gov Identifier: NCT00083915  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Multiple Myeloma
DTPACE
Tandem Transplant
Cisplatin
Cyclophosphamide
Dexamethasone
Doxorubicin
Etoposide
Sargramostim
Thalidomide
Melphalan

Study placed in the following topic categories:
Epoetin Alfa
Dexamethasone
Melphalan
Immunoproliferative Disorders
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Etoposide phosphate
Doxorubicin
Multiple Myeloma
Hemorrhagic Disorders
Cisplatin
Multiple myeloma
Lymphoproliferative Disorders
Etoposide
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Hormones
Anti-Bacterial Agents
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Hematinics
Growth Substances
Gastrointestinal Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Autonomic Agents

ClinicalTrials.gov processed this record on January 15, 2009