Table 1.

Selected High Impact Clinical Trials Ongoing or Nearing Completion in Both Newly Diagnosed Multiple Myeloma and in the Relapsed Setting

Newly diagnosed MMClinical trial status, Institution
A randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low-dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide, and low-dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant. NCT00644228Recruiting, SWOG, NCI
A phase III, randomized, open-label, 3-arm study to determine the efficacy and safety of lenalidomide (REVLIMID) plus low-dose dexamethasone when given until progressive disease or for 18 4-week cycles versus the combination of melphalan, prednisone, and thalidomide given for 12 6-week cycles in patients with previously untreated multiple myeloma who are either 65 years of age or older or not candidates for stem cell transplantation. NCT00689936Recruiting, Celgene
A trial of single autologous transplant with or without consolidation therapy versus tandem autologous transplant with lenalidomide maintenance for patients with multiple myeloma (BMT CTN 0702). NCT01109004Recruiting, NHLBI
A phase III randomized, double-blind study of maintenance therapy with CC-5013 (NSC # 703813, IND #70116] or placebo following autologous stem cell transplantation for multiple myeloma. NCT00114101Fully enrolled, CALGB
A randomized phase III study to compare bortezomib, melphalan, prednisone (VMP) with high-dose melphalan followed by bortezomib, lenalidomide, dexamethasone (VRD) consolidation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma. NCT01208766Not yet recruiting, Stichting Hemato-Oncologie voor Volwassenen Nederland
Safety and efficacy of lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma following a tandem autologous-allogeneic transplant. NCT01264315Recruiting, Fondazione Neoplasie Sangue Onlus
A randomized, open-label, phase I study of CNTO 328 (anti-IL-6 monoclonal antibody) and VELCADE-melphalan-prednisone compared with VELCADE-melphalan-prednisone for the treatment of previously untreated multiple myeloma. NCT00911859Recruiting, Centocor, Inc.
A randomized, phase III study comparing conventional-dose treatment using a combination of lenalidomide, bortezomib, and dexamethasone (RVD) to high-dose treatment with peripheral stem cell transplant in the initial management of myeloma in patients up to 65 years of age. NCT01208662Recruiting, Dana-Farber Cancer Institute
Phase III study of lenalidamide, dexamethasone followed by melphalan, prednisone, lenalidamide versus high-dose melphalan and stem cell transplantation twice followed by maintenance lenalidomide or no maintenance.Fully enrolled GEMIMA
Phase III study of high-dose melphalan and stem cell transplantation followed by lenalidamide versus no consolidation followed by lenalidomide versus no maintenance.Fully enrolled IFM
A phase III, multicenter, randomized open label study of velcade, melphalan, prednisone, and thalidomide (V-MPT) versus velcade, melphalan, prednisone (V-MP) in elderly untreated multiple myeloma patients. NCT01063179Fully enrolled GEMIMA Fondazione Neoplasie Sangue Onlus
Phase III trial of melphalan prednisone versus melphalan, prednisone, lenalidomide versus melphalan, prednisone, lenalidomide, and lenalidomide maintenance.Fully enrolled
Relapsed Setting
A randomized, multicenter, phase III study comparing carfilzomib, lenalidomide, and dexamethasone (CRd) versus lenalidomide and dexamethasone (Rd) in subjects with relapsed multiple myeloma. NCT01080391Recruiting, Onyx Therapeutics, Inc.
A phase III randomized study to assess the efficacy and safety of perifosine added to the combi- nation of bortezomib and dexamethasone in multiple myeloma patients. NCT01002248Recruiting, Keryx-AOI Pharmaceuticals, Inc.
A phase III, randomized, open label trial of lenalidomide-dexamethasone with or without elotuzumab in relapsed or refractory multiple myeloma. NCT01239797Not yet recruiting, Bristol-Myers Squibb
An international, multicenter, randomized, double-blind study of vorinostat (MK0683) or placebo in combination with bortezomib in patients with multiple myeloma. NCT00773747Ongoing, Merck
A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma. NCT01023308Recruiting, Novartis Pharmaceuticals

Abbreviations: SWOG, Southwest Oncology Group; NCI, National Cancer Institute; NHLBI, National Heart, Lung, and Blood Institute; CALGB, Cancer and Leukemia Group B; IFM, Intergroupe Francophone du MyƩlome.