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
MM-015 - A phase III, multicentre, randomised, double-blind, placebo-controlled, 3-arm parallel group study to determine the efficacy and safety of lenalidomide (REVLIMID
) in combination with melphalan and prednisone versus placebo plus melphalan and prednisone in subjects with newly diagnosed multiple myeloma who are 65 years or older. (Note: This study is being conducted outside the US.)
Melphalan in combination with prednisone is a standard treatment outside
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.
Male and female patients with newly diagnosed multiple myeloma who are 65 years or older
- Karnofsky performance status >60%.
- Able to adhere to the study visit schedule and other protocol requirements.
- 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/
L (1.5 x 109/L)
- Platelet count < 75,000 cells/
L (75 x 109/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/
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
- 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.
Phase III Randomized Study of Lenalidomide (Revlimid) as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may kill any remaining cancer cells. It is not yet known whether lenalidomide is more effective than a placebo when given after autologous stem cell transplant in treating multiple myeloma. This randomized phase III trial is studying lenalidomide to see how well it works compared to a placebo in treating patients who are undergoing autologous stem cell transplant for multiple myeloma.
S0232 - Phase III Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Newly Diagnosed Multiple MyelomaStudy Coordinators: Jeffrey A. Zonder, M.D. (313-745-8853), Bart Barlogie, M.D.,Ph.D.For further information, see the Southwest Oncology Group Web Site