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Maintenance Therapy With Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

Maintenance Therapy With Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma


PRIMARY OBJECTIVES:

I. Evaluate the toxicity of the use of Lenalidomide/Biaxin/Dexamethasone as maintenance
therapy after autologous/syngeneic transplant.

II. Evaluate the median time to disease progression. III. Evaluate survival.

OUTLINE:

Patients receive clarithromycin orally (PO) twice daily (BID) and dexamethasone PO once a
week. Treatment with clarithromycin and dexamethasone continues for up to 1 year* in the
absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide
PO once daily (QD) on days 1-14. Courses with lenalidomide repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

After completion of study treatment, patients are followed up periodically.


Inclusion Criteria:



- Any autologous or syngeneic patient who underwent high dose melphalan (>= 140 mg/m^2)
therapy/peripheral blood stem cell (PBSC) or bone marrow (BM) rescue for any stage of
multiple myeloma and did not participate in another clinical transplant trial which
is also evaluating long-term disease free survival or survival

- Platelet count (transfusion independent) > 50,000 cells/mm^3 and absolute granulocyte
count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose therapy

- Patients should be between 30 days to 120 days after transplant

- Willingness and ability to comply with Food and Drug Administration (FDA)-mandated
REV ASSIST Program, Celgene System for Lenalidomide Education and Prescribing Safety

- Signing a written informed consent form

Exclusion Criteria:

- Karnofsky score less than 70

- A left ventricular ejection fraction less than 45% immediately pre transplant;
patients with congestive heart disease with transplant, history of MI, or history of
coronary artery disease

- Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease), SGOT or
SGPT > 2.5 x upper limit of normal

- Calculated by Cockcroft-Gault formula or measured serum creatinine clearance < 25
ml/minute

- Pregnant and/or lactating females

- Patients who cannot give informed consent

- Patients with untreated systemic infection

- Patients with history prior to transplant of treatment with combination therapy
Lenalidomide/Biaxin and Steroid without response

- Patients allergic to Lenalidomide, Biaxin or Dexamethasone

- Referring physician not registered with REV ASSIST program or unwilling to oversee
the care of the patients on study and comply with the FDA-mandated REV ASSIST Program

- Patients unwilling to practice adequate forms of contraception if clinically
indicated until 30 days after stopping therapy; male patients on study need to be
consulted to use latex condoms (even if they have had a vasectomy) every time they
have sex with a woman who is able to have children while they are being treated and
for 30 days after stopping drugs

- Patients with >= grade 3 peripheral neuropathy

- Prior history of uncontrollable side effects to Dexamethasone therapy

- A prior history of human immunodeficiency virus (HIV) positivity with pre-transplant
evaluation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade IV non-hematological toxicities (except deep venous thrombosis [DVT] and pulmonary emboli) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Leona Holmberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

2135.00

NCT ID:

NCT00445692

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109