Clinical trial · Interventional
Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma
A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: Randomized phase 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clarithromycin | Drug | — | UNRESOLVED |
| prasterone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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:
* No prostate cancer or clinically significant benign prostatic hypertrophy
* No prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No malignancy suspected on mammogram
* No hypersensitivity to DHEA, clarithromycin, or any macrolide antibiotic (e.g., erythromycin)
* No insulin-dependent diabetes
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier method of contraception
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 loratadineReferences
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