17 Multiple Myeloma 1 1 0 24 24 151 http://clinicaltrials.dfhcc.harvard.edu/trials/151 Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation (HCT). Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from first dose of study drug. Patients will be followed until 28 days from completing the 12th planned cycle of lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first, (14 to 15 months after receiving the allograft) or discontinuation of study drug. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 2 255 http://clinicaltrials.dfhcc.harvard.edu/trials/255 Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 2 29 http://clinicaltrials.dfhcc.harvard.edu/trials/29 Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1/Phase 2 51 http://clinicaltrials.dfhcc.harvard.edu/trials/51 Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma The purpose of this research study is to determine the safety of CCI-779 and bortezomib, and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 is a drug that appears to stop myeloma cells from growing. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1/Phase 2 273 http://clinicaltrials.dfhcc.harvard.edu/trials/273 A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies. This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (ie, Days 1 and 11). Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1/Phase 2 359 http://clinicaltrials.dfhcc.harvard.edu/trials/359 Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of CC-4047 Alone or in Combination With Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) as treatment for patients with relapsed and refractory multiple myeloma Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1/Phase 2 1379 http://clinicaltrials.dfhcc.harvard.edu/trials/1379 Study of Oral MLN9708 in Adult Patients With Relapsed and Refractory Multiple Myeloma This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of MLN9708 administered orally in patients with relapsed and refractory multiple myeloma. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1/Phase 2 7 http://clinicaltrials.dfhcc.harvard.edu/trials/7 Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using Prostaglandin E2 (PGE2) The purpose of this research study is to determine the effects of 16, 16 Dimethyl-Prostaglandin E2 (dmPGE2) treatment on umbilical cord blood units to be used in transplantation. dmPGE2 treatment is being tested to see if it can improve the ability of umbilical cord blood stem cells to grow after transplantation. The growth of stem cells after transplantation is sometimes referred to as "engraftment". One of the major problems after umbilical cord transplantation is the time required for engraftment. After transplantation of two umbilical cord blood units, the average time to achieve engraftment is 21 days. In addition, up to 10% of patients who undergo umbilical cord blood transplantation never engraft, a potentially life-threatening condition. In laboratory studies, treatment of umbilical cord blood stem cells with dmPGE2 was shown to enhance engraftment. Recruiting 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds Phase 1 108 http://clinicaltrials.dfhcc.harvard.edu/trials/108 A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1 129 http://clinicaltrials.dfhcc.harvard.edu/trials/129 Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-Cells in Patients With Relapsed Hematologic Malignancies The purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine. Previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a way to boost their immune function and fight cancer. Information from other research studies suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in the DLI may allow for a greater effect. In this research study, we are looking for the appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given safely. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma Phase 1 138 http://clinicaltrials.dfhcc.harvard.edu/trials/138 Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1 192 http://clinicaltrials.dfhcc.harvard.edu/trials/192 Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1 298 http://clinicaltrials.dfhcc.harvard.edu/trials/298 Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating patients with relapsed or refractory multiple myeloma. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1 361 http://clinicaltrials.dfhcc.harvard.edu/trials/361 Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1 921 http://clinicaltrials.dfhcc.harvard.edu/trials/921 Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplant The proposed study is based on our observation of paradoxical tumor regression after rejection of the donor graft in conjunction with the results of our murine experiments. We hypothesize that clinically meaningful responses can be achieved in patients with advanced malignancies with a transplant strategy using nonmyeloablative conditioning and related mismatched donor stem cell transplant where the intention will be to initially achieve mixed chimerism which will be followed by recipient lymphocyte infusion (RLI) in an attempt to deliberately reject the donor graft. This will lead to the development of novel transplant strategies for achieving antitumor effects without the risk of graft versus host disease (GVHD). This proposed protocol is a Pilot Study that will evaluate the safety of this outpatient transplant strategy, i.e., establishment of initial mixed chimerism followed by RLI for donor graft rejection, in patients with advanced lymphomas, and multiple myeloma. In addition, because RLI have been reported to reverse ongoing GVHD, this approach might potentially reverse GVHD while achieving antitumor responses if this complication unexpectedly occurs. Recruiting 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma Phase 1 311 http://clinicaltrials.dfhcc.harvard.edu/trials/311 Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies The purpose of this study is to investigate possible genetic factors that contribute to the development of lymphomas. The databank will be used to determine whether familial lymphomas have unique genetic characteristics different from sporadic lymphomas and to attempt to identify a gene that confers an increased risk of lymphoma. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds N/A 181 http://clinicaltrials.dfhcc.harvard.edu/trials/181 Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Multiple Myeloma RATIONALE: Cytogenetic tests may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy. PURPOSE: This diagnostic trial is studying genetic differences in patients with treated and untreated acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or multiple myeloma. Recruiting 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma N/A 1201 http://clinicaltrials.dfhcc.harvard.edu/trials/1201 Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma This study will evaluate the safety of LBH589 given in combination with bortezomib in adult patients with multiple myeloma Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 1203 http://clinicaltrials.dfhcc.harvard.edu/trials/1203 Vorinostat (MK0683, SAHA) + Revlimid + Dexamethasone in Multiple Myeloma This is a Phase I study of vorinostat in combination with lenalidomide and dexamethasone in the patients with relapsed or refractory multiple myeloma. Patients will receive up to 8 cycles treatment with 28-day in each cycle. The safety and tolerability of the combination regimen will be evaluated in this study. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 1206 http://clinicaltrials.dfhcc.harvard.edu/trials/1206 A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 1235 http://clinicaltrials.dfhcc.harvard.edu/trials/1235 Study of Vorinostat (MK0683), an HDAC Inhibitor, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma Study of vorinostat in combination with bortezomib in patients with relapsed or refractory multiple myeloma after at least 2 prior treatment regimens. Histone deacetylases (HDAC) facilitate gene transcription by modulating the uncoiling of chromatin. HDAC function is dysregulated in hematologic and solid malignancies, and this dysregulation may result in over-expression of oncogenes. Thus, inhibition of HDACs may result in anti-cancer effects. HDAC inhibitors, like vorinostat, represent a new class of antitumor agents that have the ability to induce antiproliferative effects including cyto-differentiation, cell cycle growth arrest or apoptosis in various cancer cell lines. Several studies have investigated the in vitro antimyeloma activity of vorinostat in combination with bortezomib and have demonstrated that vorinostat may act synergistically with bortezomib to modulate tumor cell growth. Mitsiades et al have shown that vorinostat enhances the sensitivity of bortezomib. Pei et al found that exposure of human multiple myeloma cell lines & patient-derived multiple myeloma cells to bortezomib and vorinostat resulted in synergistic interactions as a result of: (1) Interruption of NF-kB & related signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of Hsp90 (3) Induction of ER stress signal and (4) acetylation of Dynein/ disruption of aggresome function/formation, salvage for ubiquinated proteins. In addition a marked increase in mitochondrial injury, caspase activation, and apoptosis was also observed. Bortezomib is indicated for the treatment of patients with multiple myeloma. Two Phase I dose-ranging studies of a regimen combining vorinostat and bortezomib among patients with relapsed as well as end-stage, refractory multiple myeloma have been conducted. These studies enrolled a total of 57 patients. In these studies, administration of vorinostat with standard doses of bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al 2007, Badros et al 2007). The purpose of the present study is to definitively evaluate the clinical activity of vorinostat in combination with bortezomib in patients with multiple myeloma Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 1245 http://clinicaltrials.dfhcc.harvard.edu/trials/1245 Study of Vorinostat (MK0683) an HDAC Inhibitor, or Placebo in Combination With Bortezomib in Patients With Multiple Myeloma Study of bortezomib administered in combination with vorinostat or placebo in patients with relapsed or refractory multiple myeloma. Histone deacetylases (HDAC) facilitate gene transcription by modulating the uncoiling of chromatin. HDAC function is dysregulated in hematologic and solid malignancies, and this dysregulation may result in over-expression of oncogenes. Thus, inhibition of HDACs may result in anti-cancer effects. HDAC inhibitors, like vorinostat, represent a new class of antitumor agents that have the ability to induce antiproliferative effects including cyto-differentiation, cell cycle growth arrest or apoptosis in various cancer cell lines. Several studies have investigated the in vitro antimyeloma activity of vorinostat in combination with bortezomib and have demonstrated that vorinostat may act synergistically with bortezomib to modulate tumor cell growth. Mitsiades et al have shown that vorinostat enhances the sensitivity of bortezomib. Pei et al found that exposure of human multiple myeloma cell lines & patient-derived multiple myeloma cells to bortezomib and vorinostat resulted in synergistic interactions as a result of: (1) Interruption of NF-kB & related signaling pathways (JNK, XIAP, Mcl-1, etc.) (2) Inhibition of Hsp90 (3) Induction of ER stress signal and (4) acetylation of Dynein/ disruption of aggresome function/formation, salvage for ubiquitinated proteins. In addition a marked increase in mitochondrial injury, caspase activation, and apoptosis was also observed. Bortezomib is indicated for the treatment of patients with multiple myeloma. Two Phase I dose-ranging studies of a regimen combining vorinostat and bortezomib among patients with relapsed as well as end-stage, refractory multiple myeloma have been conducted. These studies enrolled a total of 57 patients. In these studies, administration of vorinostat with standard doses of bortezomib resulted in responses in 20/45 (44%) evaluable patients (Weber et al 2007, Badros et al 2007). The purpose of the present study is to definitively evaluate the clinical activity of vorinostat in combination with bortezomib in patients with multiple myeloma Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 1380 http://clinicaltrials.dfhcc.harvard.edu/trials/1380 A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients. The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy. In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy. This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment. The purpose of the phase II portion of the study, is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo. A skeletal-related event is defined as: - Pathologic fracture - Spinal cord compression - Requirement for either radiation or surgery to bone due to: - Pain - Prevention of imminent fracture - Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine. Charges in serum DKK1 levels will be characterized. The size and number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and at selected sites with QCT scans. Recruiting 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 1445 http://clinicaltrials.dfhcc.harvard.edu/trials/1445 Evaluating the Safety and Effectiveness of a Bone Marrow Transplant From Partially Matched Donors and Using Low Dose Chemotherapy in People With Leukemia or Lymphoma (BMT CTN #0603) Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family members or unrelated donors with a similar type of bone marrow usually donate their bone marrow to the transplant patients. This study will evaluate the effectiveness of a new type of bone marrow transplant—one that uses lower doses of chemotherapy and bone marrow donated from family members with only partially matched bone marrow—in people with leukemia or lymphoma. Recruiting 14 Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/14-hodgkin-s-lymphoma 11 Leukemia/MDS http://clinicaltrials.dfhcc.harvard.edu/diagnoses/11-leukemia-mds 17 Multiple Myeloma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/17-multiple-myeloma 15 Non-Hodgkin's Lymphoma http://clinicaltrials.dfhcc.harvard.edu/diagnoses/15-non-hodgkin-s-lymphoma