Combination Chemotherapy in Treating Patients With Multiple Myeloma - Article
Clinical Trial: Combination Chemotherapy in Treating Patients With Multiple Myeloma
This study is no longer recruiting patients.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.
|Condition||Treatment or Intervention||Phase|
|stage I multiple myeloma |
stage II multiple myeloma
stage III multiple myeloma
| Drug: dexamethasone |
|Phase III |
MedlinePlus related topics: Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Melphalan Combined With Dexamethasone or Prednisone As Induction Therapy With or Without Dexamethasone as Maintenance Therapy in Patients With Previously Untreated Stage I-III Multiple Myeloma
- Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.
- Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.
- Compare the time to progression, response rate, and quality of life of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).
- Patients are randomized to 1 of 4 treatment arms.
- Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4.
- Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3. Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy.
- Arms I and III: Patients undergo observation.
- Arms II and IV: Patients receive oral DM on days 1-4. Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity. Patients on arms I-IV who develop disease progression proceed to reinduction.
- Reinduction: Patients restart induction on the arm to which they were originally randomized. Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks, disease progression, or unacceptable toxicity. Patients who achieve a stable response lasting 16 weeks restart maintenance therapy. Patients who experience further disease progression during reinduction are taken off study. Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Histologically proven previously untreated stage I-III multiple myeloma
- Patients with stage I disease must be symptomatic
- Must meet at least 1 of the following conditions:
- Plasma cells in osteolytic lesion or soft tissue tumor biopsy
- At least 10% plasmacytosis in bone marrow aspirate and/or biopsy
- Less than 10% plasma cells in bone marrow but at least 1 bony lesion
- Detectable serum M-component of IgG, IgA, IgD, or IgE
- If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours
PATIENT CHARACTERISTICS: Age:
- 18 and over
- ECOG 0-4
- Not specified
- Not specified
- Not specified
- Not specified
- No other concurrent serious illness
- Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed
- No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy:
- No concurrent immunizations
- No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis
- Concurrent epoetin alfa for anemia allowed
- No prior chemotherapy
- Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg
- Prior or concurrent corticosteroids for hypercalcemia allowed
- See Endocrine therapy
- Prior focal radiotherapy allowed
- Concurrent focal radiotherapy during induction allowed
- Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed
- At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer
- At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer
- Prior or concurrent bisphosphonates for hypercalcemia allowed
St. Mary's/Duluth Clinic Health System, Duluth, Minnesota, 55805, United States
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Tom Baker Cancer Center - Calgary, Calgary, Alberta, T2N 4N2, Canada
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria, British Columbia, V8R 6V5, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada
Providence Health Care - Vancouver, Vancouver, British Columbia, V6Z 1Y6, Canada
Canada, New Brunswick
Doctor Leon Richard Oncology Centre, Moncton, New Brunswick, E1C 8X3, Canada
Moncton Hospital, Moncton, New Brunswick, E1C 6ZB, Canada
Saint John Regional Hospital, Saint John, New Brunswick, E2L 4L2, Canada
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada
Canada, Nova Scotia
Nova Scotia Cancer Centre, Halifax, Nova Scotia, B3H 2Y9, Canada
Algoma District Medical Group, Sault Sainte Marie, Ontario, P6B 1Y5, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, N8W 2X3, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, L8V 5C2, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, N6A 4L6, Canada
Credit Valley Hospital, Mississauga, Ontario, L5M 2N1, Canada
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, L2R 5K3, Canada
Humber River Regional Hospital, Weston, Ontario, M9N 1N8, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, K7L 5P9, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, L1G 2B9, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, Ontario, P3E 5J1, Canada
Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada
Southlake Regional Health Centre, Newmarket, Ontario, L3Y 2P9, Canada
St. Michael's Hospital - Toronto, Toronto, Ontario, M5B 1W8, Canada
Toronto East General Hospital, Toronto, Ontario, M4C 3E7, Canada
Toronto General Hospital, Toronto, Ontario, M5G 2C4, Canada
Toronto Sunnybrook Regional Cancer Centre, Toronto, Ontario, M4N 3M5, Canada
Trillium Health Centre, Mississauga, Ontario, L5B 1B8, Canada
William Osler Health Centre, Brampton, Ontario, L6W 2Z8, Canada
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI, Charlottetown, Prince Edward Island, C1A 8T5, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, J1H 5N4, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, J4V 2H1, Canada
Hopital de L'Enfant Jesus, Quebec City, Quebec, G1J 1Z4, Canada
Hopital du Saint-Sacrement, Quebec, Quebec City, Quebec, G1S 4L8, Canada
McGill University, Montreal, Quebec, H2W 1S6, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, S4T 7T1, Canada
Chaim Shustik, MD, Study Chair, Royal Victoria Hospital - Montreal
Shustik C, Belch A, Meyer R, et al.: Melphalan-dexamethasone is not superior to melphalan-prednisone as induction therapy in multiple myeloma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1191, 2001.
Record last reviewed: September 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002678
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005