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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083915 |
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 |
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Multiple Myeloma |
Drug: Cisplatin Drug: Cyclophosphamide Drug: Dexamethasone Drug: Doxorubicin Drug: Etoposide Drug: Sargramostim Drug: Melphalan Drug: Thalidomide Drug: Erythropoietin |
Phase III |
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 |
Estimated Enrollment: | 540 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | June 2013 |
Arms | Assigned Interventions |
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences/MIRT | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Guido J Tricot, M.D., Ph.D. | UAMS |
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 |
Multiple Myeloma DTPACE Tandem Transplant Cisplatin Cyclophosphamide Dexamethasone |
Doxorubicin Etoposide Sargramostim Thalidomide Melphalan |
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 |
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 |