Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT00151203 |
Recruitment Status :
Completed
First Posted : September 8, 2005
Last Update Posted : May 27, 2021
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PRIMARY STUDY OBJECTIVES
- To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
- To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM.
SECONDARY STUDY OBJECTIVES
- To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide.
- To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Clarithromycin, Lenalidomide, Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma |
Actual Study Start Date : | December 2004 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | September 29, 2020 |

- Drug: Clarithromycin, Lenalidomide, Dexamethasone
Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1, 2, 3, 8, 15 and 22 during the first cycle and once a week on days 1, 8, 15, and 22 for each subsequent cycle.
Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1.
Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 3 and ending on day 21 of cycle 1 and on days 1-21 of subsequent cycles.
- Response rate, time to maximum response, toxicities [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must voluntarily sign and understand written informed consent.
- Histologically confirmed Durie-Salomon stage II or III MM (see Appendix II). Stage I MM patients will be eligible if they display poor prognostic factors (ß2M > or = 5.5 mg/L, plasma cell proliferation index > or = 5%, albumin of less then 3.0, and unfavorable cytogenetics).
- Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- Age > or = 18 years at the time of signing the informed consent form.
- Karnofsky performance status > or = 70% (>60% if due to bony involvement of myeloma (see Appendix V).
- No prior treatment or less than one full course of first-line therapy. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
- If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study.
- Due to the unknown risk of teratogenic side effects, subjects (women and men) must agree to use effective contraception throughout the duration of the study and for at least 1 month after discontinuation of study drugs.
- Life expectancy > 3 months
- Absolute neutrophil count (ANC)> or = 1000 cells/mm3 (1.0 x 109/L)
- Platelets count > or = 75,000/mm3 (75 x 109/L)
- Serum SGOT/AST < 3.0 x upper limits of normal (ULN)
- Serum SGPT/ALT < 3.0 x upper limits of normal (ULN)
- Serum creatinine < 2.5 mg/dL (221 µmol/L)
- Serum total bilirubin < 2.0 mg/dL (34 µmol/L)
Exclusion Criteria:
- Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
- NYHA Class III or IV heart disease. History of active angina, congestive heart disease, or myocardial infarction within 6 months.
- Pregnant or lactating women are ineligible.
- Known HIV positivity
- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide.
- Prior therapy for the treatment of MM
- History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin are eligible.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151203
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 |
Principal Investigator: | Ruben Niesvizky, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00151203 |
Other Study ID Numbers: |
0409007427 |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | May 27, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
newly diagnosed multiple myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Clarithromycin |
Dexamethasone Lenalidomide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors |