Know Cancer

forgot password

A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate, time to maximum response, toxicities

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ruben Niesvizky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • newly diagnosed multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Weill Medical College of Cornell University New York, New York  10021