E1A05 - A Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®) & Lenalidomide (Revlimid®) - Dexamethasone (VRD) versus Bortezomib (Velcade®) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen

Melphalan in combination with prednisone is a standard treatment outside North America for elderly patients with newly diagnosed multiple myeloma.Lenalidomide in combination with dexamethasone has been shown to be of benefit to patients with multiple myeloma who have received prior therapy. Preliminary results from a phase I/II trial also indicate that lenalidomide in combination with melphalan and prednisone may add additional benefit to elderly newly diagnosed multiple myeloma. The aim of the MPR trial is confirm whether lenalidomide in combination with melphalan and prednisone will increase progression free survival when compared to placebo plus melphalan and prednisone in newly diagnosed multiple myeloma patients aged 65 or older.

Eligibility

Male and female patients with newly diagnosed multiple myeloma who are 65 years or older

Inclusion Criteria

1. Karnofsky performance status >60%.
   
2. Able to adhere to the study visit schedule and other protocol requirements.

Female Subjects:

• Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual intercourse during the time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.

• Must agree to use a latex condom during any sexual contact with FCBP while participating in this study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.

• Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.

• Must agree to abstain from donating semen or sperm during study participation and for at least 28 days after discontinuation from the study.

1. Previous treatment with antimyeloma therapy

2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk

3. Radiotherapy or plasmapheresis within 28 days (4 weeks) of randomisation.

4. Any of the following laboratory abnormalities:

Absolute neutrophil count (ANC) < 1,500 cells/ µ L (1.5 x 10⁹/L)

Platelet count < 75,000 cells/ µ L (75 x 10⁹/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/ µ L for subjects in whom >50% of bone marrow nucleated cells are plasma cells

Haemoglobin < 8.0 g/dL (80 g/L)

Serum creatinine > 2.5 mg/dL (221 µ mol/L)

Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

5. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >3 years.

6. Neuropathy of >grade 2 severity.

7. Known HIV positivity or active infectious hepatitis, type A, B or C.

You can learn more about this trial by reviewing the NCI database entry for this trial.

Revlimid from the Celgene Corporation was just approved by the Food and Drug Administration to treat certain patients with a malignant blood condition called MDS.