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Dexamethasone

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Cytoxan

G-CSF

Athanasios Fassas, M.D.

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.

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.

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

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

University of Arkansas

Pharmaceutical Solutions

Cytarabine

Doxorubicin

Liposomal doxorubicin

Vincristine

Melphalan

Lenograstim

Carmustine

Interferons

Interferon-alpha

Interferon alpha-2

Tobramycin, Dexamethasone Drug Combination

Antibiotics, Antitubercular

Antiviral Agents

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Thalidomide 400 qod during induction.100 mg qd between transplants, post transplant pat. 200 mg qd. During year one of maintenance therapy pt will take 100mg of Thal qod and 50 mg of thal qod during second year of maintenance

During induction, consolidation, and maintenance steps patient receives no thalidamide

All patients will be randomly assigned to receive thalidomide 400 mg as an oral, once daily dose throughout induction and 100mg between transplants after platelets are greater than 50,000μl and 200 mg post transplant consolidation, and a reduced dose of 100 mg on alternating days during the first year of maintenance and 50 mg qod thereafter versus no thalidomide. Thalidomide will be held during conditioning, transplant procedure, and recovery following transplant. It may be resumed once plateletrecovery is complete after each transplant

Cytarabine (Ara-C) 400 mg/m2 in 250 ml D5W over one hour daily for four days (on days -5, -4, -3, -2).

Start infusion 30 minutes after completion of BCNU on day -5.

Ara-C

Carmustine (BCNU) 300 mg/m2 in 1 liter of D5W in glass bottle (protect from light) to infuse over 2 hours on day -5. Check blood pressure every 15 minutes during infusion and 30 minutes after completion

BCNU

Cisplatin\* 15 mg/m2/day Continuous infusion 1-4 (DCEP CYCLE 2) Cisplatin\* 7.5 mg/m2 Continuous infusion 1-4 (DPACE cycle)

\*Cisplatin doses will be modified for renal insufficiency as follows: Cisplatin dose Creatinine 15 mg/m2 (full dose) \< 1.5 mg/dl 10 mg/m2 1.6 - 2.0 mg/dl 7.5 mg/m2 2.1 - 3.0 mg/dl 0 mg (hold Cisplatin) \> 3.0 mg/dl

Cycle 2 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cycle 3 - CAD and PBSC Collection #1 Cyclophosphamide 750 mg/m2/day Continuous infusion 1-4 Cycle 4 - DCEP Cyclophosphamide 400 mg/m2/day Continuous infusion 1-4 Cytoxan/VP-16 and PBSC Collection-Cyclophosphamide 2 grams/m2 (Total dose 4 gm/m2) IV by CI 1 and 2 Post-Transplant Consolidation-Cyclophosphamide 300 mg/m2 Continuous infusion 1-4

Induction cycle 1 VAD Dexamethasone 40 mg/day PO 1-4, 9-12, 17-20 Cycle 2 - DCEP Dexamethasone 40 mg/day PO 1-4 Cycle 3 - CAD and PBSC Collection #1 Dexamethasone 40 mg/day PO 1-4 Cycle 4 - DCEP and PBSC Collection #2 Dexamethasone 40 mg/day PO 1-4 Post-Transplant Consolidation Dexamethasone 40 mg PO 1-4 Dexamethasone Consolidation Patients that do not achieve adequate platelet recovery (defined as \< 80,000/μl) will receive consolidation with Dexamethasone 40 mg x 4 days every 28 days for 1 year Maintenance year one Dexamethasone 40 mg PO q 3 months, day 1-4, 9-12, 17-20

Doxorubicin may be further diluted in 5% dextrose or sodium chloride injection and should be administered slowly into tubing of a freely flowing intravenous infusion with great care taken to avoid extravasation.

Etoposide (VP16) 200 mg/m2 in 500 ml D5W over one hour daily for four days (on days -5, -4, -3, -2). Start infusion 30 minutes after completion of BCNU on day -5. Start infusion at completion of cytarabine on following three days

G-CSF will be administered at a dose of 10mcg/kg or GM-CSF at a dose of 10 mcg/kg. G-CSF or GM-CSF will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.

Filgrastim

GM-CSF at a dose of 10 μg/kg SC, divided in 2 doses each day, will begin one day after completion of chemotherapy and continued during repeated apheresis and discontinued upon completion of apheresis.

Recombinant GM-CSF

AGENT DOSE ROUTE DAYS Intron-A 3 million units/m2 SQ TIW Thalidomide (for those randomized at initial registration) 50 mg QOD PO Every other day (qod

Interferon-alpha-2b

Formulation: 1 mg/1 ml, 2 mg/2 ml, and 5 mg/ 5 ml vials. Vincristine should be administered intravenously through a freely-running IV. If it extravasates, it produces a severe local reaction with skin slough. FATAL IF GIVEN INTRATHECALLY, FOR INTRAVENOUS USE ONLY.

Bart Barlogie, M.D., Ph.D.

This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.

Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation, and maintenance. Induction is designed to induce (or bring about) myeloma into remission. Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide. Some patients may be eligible to receive the transplant as an outpatient, based on general health and other factors.After recovery from the transplant phase of the study (approximately 6 weeks), patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment. All patients will receive post-transplant consolidation treatment, which in earlier studies has been found to be helpful in maintaining patients response after transplant. Therefore, all patients will receive a combination of drugs called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide. If you are also taking thalidomide, you will continue taking it throughout, and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks, and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete, you will begin the last phase of the study, which is maintenance. Maintenance is designed to keep your myeloma in remission long-term.

UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

Overall Survival at six years after initiating protocol therapy

Celgene Corporation

Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.

Patient received no thalidomide during induction, consolidation, and maintenance therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse	NCT00083681	Multiple Myelom...	Thalidomide Dexamethasone Cytoxan Etoposide Cisplatin G-CSF	18 Years -	University of Arkansas
DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse	NCT00083681	Multiple Myelom...	Thalidomide Dexamethasone Cytoxan Etoposide Cisplatin G-CSF	18 Years -	University of Arkansas
DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse	NCT00083681	Multiple Myelom...	Thalidomide Dexamethasone Cytoxan Etoposide Cisplatin G-CSF	18 Years -	University of Arkansas
UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy	NCT00083551	Multiple Myelom...	Thalidomide Ara-C BCNU Cisplatin Cytoxan Dexamethasone Doxorubicin Etoposide Filgrastim Recombinant GM-... Interferon-alph... Melphalan Vincristine	18 Years - 75 Years	University of Arkansas

Spots Global Cancer Trial Database for dcep

Every month we try and update this database with for dcep cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dcep

Every month we try and update this database with for dcep cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dcep cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.