Clinical Trial: Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma

This study is no longer recruiting patients.

Sponsors and Collaborators: Mayo Clinic Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma.

PURPOSE: Randomizedphase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.

Condition Treatment or Intervention Phase
Multiple Myeloma
 Drug: clarithromycin
 Drug: dehydroepiandrosterone
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
Phase II

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Prevention

Official Title: Phase II Randomized Chemoprevention Study of Dehydroepiandrosterone (DHEA) Versus Clarithromycin in Patients With Monoclonal Gammopathy of Undetermined or Borderline Significance

Further Study Details: 

OBJECTIVES:

  • Determine whether dehydroepiandrosterone (DHEA) or clarithromycin causes a significant reduction in bone marrow plasmacytosis, serum and/or urine M protein or Bence Jones protein, and surrogate endpoint biomarkers in patients with monoclonal gammopathy of undetermined or borderline significance.
  • Determine whether differences in interleukin-1-beta (IL-1-beta) expression and IL-1-beta dependent biomarkers (adhesion molecule expression and serum interleukin-6 levels) are useful surrogate endpoint biomarkers in these patients.
  • Determine whether differences in ploidy, proliferative index, nuclear pleomorphism index, circulating monoclonal plasma cells, Th1/Th2 ratios, serum s-interleukin-6R (SIL-6R) levels, interleukin-6 and SIL-6R expression, or plasma cell apoptosis assay are useful surrogate endpoint biomarkers in these patients.
  • Determine the effects of these treatment regimens on the quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to disease (monoclonal gammopathy of undetermined significance vs monoclonal gammopathy of borderline significance) and monoclonal protein abnormality (IgG vs IgA). Patients are randomized to 1 of 4 treatment arms.

Quality of life is assessed at baseline, 6 months, 12 months, and then at disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 1.5 years.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arms I and II and 25 between arms III and IV) will be accrued for this study within 2.5 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • New or prior diagnosis of 1 of the following:
  • Monoclonal gammopathy of undetermined significance
  • Bone marrow plasma cells of less than 10%
  • Monoclonal gammopathy of borderline significance
  • Bone marrow plasma cells of 10-30%
  • Serum IgG or IgA at least 1.5 g/dL
  • Bone marrow plasmacytosis no greater than 30%
  • No multiple myeloma, amyloidosis, or B-cell neoplasm
  • No evidence of bone lesions
  • Prostate-specific antigen less than 4 ng/mL

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless history of Gilbert's disease)
  • AST and ALT no greater than 1.5 times ULN (unless history of Gilbert's disease)

Renal:

  • Creatinine no greater than 1.8 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No prior thromboembolic event within the past 5 years

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • At least 30 days since prior DHEA or other steroids that may affect M protein

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 30 days since prior clarithromycin
  • At least 30 days since any other prior agents that may affect M protein
  • No concurrent cisapride, terfenadine, pimozide, astemizole, or loratadine

Location Information


Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States

Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

Study chairs or principal investigators

John A. Lust, MD, PhD,  Study Chair,  Mayo Clinic - Rochester   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068084; MAYO-979202; NCI-P00-0163
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006219
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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