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Phase 3
18 Years
80 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Inclusion Criteria

1. Patients must have newly diagnosed multiple myeloma

2. Patients must have received no prior chemotherapy for this disease. Patients must
have received no prior radiotherapy to a large area of the pelvis (more than half of
the pelvis). Prior steroid treatment is allowed provided treatment was not more than
2 weeks in duration. Patients must not have received any prior treatment with
bortezomib or lenalidomide.

3. Patients must be ≥ 18 years of age at the time of registration.

4. Patients must have a Zubrod Performance Status (PS) of 0 - 3

5. Patients must have adequate marrow function as defined herein:

6. Platelet count ≥ 80 x 103/mcL,

7. ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused
or treated with EPO) ≥ 9 g/dL.

8. Institutions must submit a local cytogenetics report and FISH analysis report

9. Patients with pathologic fractures, pneumonia at diagnosis or symptomatic

10. Patients must have a calculated or measured creatinine clearance > 30 cc/min.

11. Patients must not have uncontrolled, active infection requiring intravenous

12. Patients must not have any psychiatric illness

13. Patients must not be Hepatitis B, Hepatitis C or HIV positive

14. Patients must not have a history of cerebral vascular accident with persistent
neurologic deficits.

15. Patients must be able to take aspirin 325 mg daily

16. Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test

17. No prior malignancy is allowed except for adequately treated basal cell (or squamous
cell) skin cancer, in situ cervical cancer or other cancer for which the patient has
been disease-free for five years.

18. Patients must be offered participation in GEP molecular studies for the evaluation of
genetic polymorphisms.

Type of Study:


Study Design:

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

Outcome Measure:

comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone

Outcome Time Frame:

Four years

Safety Issue:



United States: Federal Government

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Untreated
  • Without intent for immediate autologous stem cell transplant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell