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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Athanasios Fassas, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UAMS
Authority:
United States: Food and Drug Administration
Study ID:
UARK 98-018
NCT ID:
NCT00083681
Start Date:
June 1998
Completion Date:
May 2005
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Thalidomide
- G-CSF
- Cisplatin
- Etoposide
- Dexamethasone
- Cytoxan
- DCEP
- Relapse
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences/MIRT | Little Rock, Arkansas 72205 |
