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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Dexamethasone
Cytoxan
Etoposide
Cisplatin
G-CSF
Sponsored by
University of Arkansas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Thalidomide, G-CSF, Cisplatin, Etoposide, Dexamethasone, Cytoxan, DCEP, Relapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences/MIRT

Outcomes

Primary Outcome Measures

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

To evaluate the quantitative and qualitative toxicities associated with the regimens.

Full Information

First Posted
May 27, 2004
Last Updated
July 1, 2010
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00083681
Brief Title
DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Thalidomide, G-CSF, Cisplatin, Etoposide, Dexamethasone, Cytoxan, DCEP, Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Cytoxan
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
G-CSF
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the quantitative and qualitative toxicities associated with the regimens.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios Fassas, M.D.
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://myeloma.uams.edu
Description
Myeloma Institute for Research & Therapy website

Learn more about this trial

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

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