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Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma Clinical research trials and Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma. Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma clinical trial. Participants typically obtain the most effective healthcare available for their Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma  Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
For Condition: stage 2 multiple myeloma,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): West of Scotland Lymphoma Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapyregimen is more effective for multiple myeloma. PURPOSE: Randomizedphase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage II or stage III multiple myeloma.
Details: OBJECTIVES: - Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprised of idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone. - Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens. - Compare the quality of life of patients treated with these 2 regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only. - Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I. Patients without a maximal response after completion of course 4 may receive up to 2 additional courses. Quality of life is assessed at baseline and then prior to each study course. Patients are followed for survival. PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage II or III multiple myeloma - No prior therapy except local radiotherapy to bone lesions - No indolent multiple myeloma - No monoclonal gammopathy of unknown significance PATIENT CHARACTERISTICS: Age: - 75 and under Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.34 mg/dL Renal: - No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration) - No requirement for dialysis Other: - No other medical condition that would preclude intensive treatment - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics Radiotherapy - Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GordonCook, Study Chair, Monklands General Hospital
Royal Liverpool and Broadgreen Hospitals *Recruiting*
Liverpool, England, L7 8XP
United Kingdom
Recruiting Richard Clark 44-151-706-4344
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Norman Lucie 44-141-211-2765
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting Dominic Culligan 44-1224-553-394
New Cross Hospital *Recruiting*
Wolverhampton, England, WV10 0QP
United Kingdom
Recruiting A. MacWhannell 44-1902-307-999
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting David Bowen 44-1382-660-111
Monklands General Hospital *Recruiting*
Airdrie, Wales, ML6 0JF
United Kingdom
Recruiting Gordon Cook 44-1236-748-748
Birmingham Heartlands and Solihull NHS Trust -Teaching *Recruiting*
Birmingham, England, B9 5SS
United Kingdom
Recruiting R Johnson 44-121-424-2000
Dumfries Royal Infirmary *Recruiting*
Dumfries, Scotland, DG1 4AP
United Kingdom
Recruiting Allistair Stark 44-1387-246-246
Belfast City Hospital Trust *Recruiting*
Belfast, Northern Ireland, BT9 7AB
United Kingdom
Recruiting T.C.M. Morris 44-028-9032-9241
Royal Infirmary *Recruiting*
Glasgow, Scotland, G4 0SF
United Kingdom
Recruiting Grant Mcquaker 44-141-211-4672
Vale Of Leven D G Hospital *Recruiting*
Alexandria, Scotland, G83 0UA
United Kingdom
Recruiting Patricia Clarke 004401389 754121
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting J. Craig 44-1223-217-071
Royal Alexandra Hospital *Recruiting*
Paisley, Scotland,
United Kingdom
Recruiting Pamela Mckay 44-141-580-4225
Additional Information:
Study ID Numbers: CDR0000068156; EU-20032,WSLG-H31
Study Start Date:
Record last reviewed: September 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006232
Other Stage 2 Multiple Myeloma Studies:
1. Total-Body Irradiation, Busulfan, and Interferon alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma
2. High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
3. Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
5. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Scotland Clinical Trials
Other Dumfries Clinical Trials
Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
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