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DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083681
Recruitment Status : Completed
First Posted : May 28, 2004
Last Update Posted : July 2, 2010
Information provided by:
University of Arkansas

Brief Summary:
The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a four day chemotherapy regimen involving dexamethasone, cytoxan, etoposide, and cisplatinum, or DCEP with or without thalidomide. Another purpose is to find out what kind of side effects patients will experience.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide Drug: Dexamethasone Drug: Cytoxan Drug: Etoposide Drug: Cisplatin Drug: G-CSF Phase 2

Detailed Description:

Each patient enrolled to this study will be assigned to either receive DCEP alone, or in combination with thalidomide. Since it is not known at this time which treatment is the best, you will be placed by chance in one of the two groups.

Treatment consists of three cycles of combination chemotherapy, each over four days. Three drugs, Cytoxan, etoposide, and cisplatin will be given into the vein as a continuous four-day infusion. Decadron will be given by mouth over four days. G-CSF will also be given daily as a shot under the skin to help bone marrow recover.

After 3 cycles of combination chemotherapy, your myeloma will be reassessed. If myeloma is stable or responding, patients will receive an additional 3 cycles of chemotherapy. Then myeloma will again be reassessed and if again found to be stable or responding,3 final cycles of chemotherapy will be given.

Following the completion of chemotherapy, or sooner if your physician feels that the chemotherapy side effects are to great, patients will receive maintenance therapy with dexamethasone. Patients originally assigned to receive thalidomide, will continue to take thalidomide daily throughout protocol treatment.

The major reason for conducting this research is to gather biologic information from patients who have myeloma. Information gained from such research may contribute to a greater understanding of the reasons for treatment failure and may assist in the selection of appropriate treatment for individual patients.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UARK 98-018, A Randomized Phase II Trial of DCEP or DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse in Patients With Multiple Myeloma
Study Start Date : June 1998
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

Primary Outcome Measures :
  1. To evaluate the effectiveness of the DCEP chemoregimen with G-CSF support as compared to the DCEP regimen with G-CSF support in combination with thalidomide in high risk patients relapsing after autologous transplantation.

Secondary Outcome Measures :
  1. To evaluate the quantitative and qualitative toxicities associated with the regimens.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with relapse or progression following at least one autologous transplant. High risk is defined as any one of the following at the time of relapse:a) Plasma cell labeling index (PCLI) > 1%, b) Bone marrow plasmacytosis > or = 30%, c)Bartl grade >or = 2 on bone marrow biopsy, or d)Cytogenetic abnormalities of chromosome 13, 11q, or any translocation at the time of relapse.
  • Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
  • Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
  • Patients must have a SWOG performance status of 0-2. Patients with a poor performance status (3-4) based solely on bone pain, will be eligible.
  • Patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl
  • Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. Written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. Pregnancy testing is not required for 1) women wh have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
  • Patients must have adequate bone marrow function, as defined by platelet count of 150,000/microliter, unless explained by extensive marrow plasmacytosis.
  • Patients must be off chemotherapy (excluding steroids) and local radiotherapy for > 3 weeks prior to entering the study

Exclusion Criteria:

  • There must be no evidence of active infection requiring IV antibiotics
  • No other concurrent therapy for myeloma is permitted while on protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00083681

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United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
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Principal Investigator: Athanasios Fassas, M.D. UAMS
Additional Information:
Layout table for additonal information Identifier: NCT00083681    
Other Study ID Numbers: UARK 98-018
First Posted: May 28, 2004    Key Record Dates
Last Update Posted: July 2, 2010
Last Verified: July 2010
Keywords provided by University of Arkansas:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents