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A COMPARATIVE STUDY OF DEXAMETHASONE VERSUS PREDNISONE (BOTH IN COMBINATION WITH MELPHALAN) AS INDUCTION THERAPY IN UNTREATED SYMPTOMATIC MYELOMA WITH AN ADDITIONAL ASSESSMENT OF DEXAMETHASONE VERSUS NO ADDITIONAL TREATMENT AS MAINTENANCE THERAPY IN NON-PROGRESSING PATIENTS


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A COMPARATIVE STUDY OF DEXAMETHASONE VERSUS PREDNISONE (BOTH IN COMBINATION WITH MELPHALAN) AS INDUCTION THERAPY IN UNTREATED SYMPTOMATIC MYELOMA WITH AN ADDITIONAL ASSESSMENT OF DEXAMETHASONE VERSUS NO ADDITIONAL TREATMENT AS MAINTENANCE THERAPY IN NON-PROGRESSING PATIENTS


OBJECTIVES:

- 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).

- Induction: 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.

- Maintenance:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

Performance status:

- ECOG 0-4

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- 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

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- 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

Radiotherapy:

- 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

Surgery:

- At least 2 years since prior surgery for radiologic or endoscopic diagnosis of
gastric or duodenal ulcer

Other:

- At least 2 years since prior medication for radiologic or endoscopic diagnosis of
gastric or duodenal ulcer

- Prior or concurrent bisphosphonates for hypercalcemia allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

To compare overall survival between: i) patients receiving melphalan-prednisone and those receiving melphalan-dexamethasone as induction therapy ii) patients maintained by dexamethasone and those on no additional treatment in the subgroup whose disease has not progressed at the time of the 12th induction cycle

Outcome Time Frame:

9 years

Safety Issue:

No

Principal Investigator

Chaim Shustik, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Victoria Hospital - Montreal

Authority:

Canada: Health Canada

Study ID:

MY7

NCT ID:

NCT00002678

Start Date:

May 1995

Completion Date:

December 2009

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

St. Mary's/Duluth Clinic Health SystemDuluth, Minnesota  55805