View clinical trials related to Neoplasms, Plasma Cell.
Filter by:The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to determine the safety and tolerability of immunizations when administered prior to stem cell mobilization and multiple times after stem cell reinfusion. Secondary objectives were to assess the humoral and cellular immunogenicity and clinical outcomes of immunization.
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma. The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous. This study expects to enroll approximately 80 subjects from participating VA sites across the nation. The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and administration of two cycles BVP over followed by autologous transplant. In addition to the overall response rates, will also be analyzed time to progression (TTP), progression-free survival (PFS) and overall survival. Finally, the results will be compared with BVP with those obtained in 120 patients included in our protocol VMP GEM10MAS65. Patients will be evaluated at scheduled visits up to 3 periods of study: pretreatment, treatment and monitoring.
This phase I trial studies the side effects and best dose of filanesib when given together with carfilzomib in treating patients with multiple myeloma or plasma cell leukemia that has returned or does not respond to treatment. Drugs used in chemotherapy, such as filanesib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filanesib together with carfilzomib may be a better treatment for multiple myeloma or plasma cell leukemia.
The purpose of this study is to evaluate tolerability of the combination therapy of JNS002 and bortezomib in Japanese bortezomib-naive patients with multiple myeloma who have ever received at least 1 line of chemotherapy.
Based the proven efficacy and the ability to induce rapid response of various combinations of bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.
This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the same bortezomib-containing combination regimen to which a MM patient has progressed while receiving. This study will enroll 45 patients total. These patients will be resistant to bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed within 12 weeks of the last dose of bortezomib in a combination regimen. Patients will be sub-divided into 2 groups in this study, treatments containing (Group A) or not containing immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and 15 patients into Group B for a total of 45 patients. Patients must have received 4 doses of a minimum of 1.0 mg/m^2 of bortezomib in no more than 4 weeks per cycle. Patients must have received at least one cycle meeting this definition and have shown progressive disease to be considered eligible. Patients who have been refractory to or relapsed within 12 weeks of the last dose of bortezomib in their most recent bortezomib-containing regimen that does not include either thalidomide or lenalidomide are eligible regardless of when patients received that regimen, as long as they meet the above criteria. Carfilzomib will subsequently replace bortezomib using the patient's most recent bortezomib-containing regimen to which the patient progressed while receiving. Patients will be eligible if they progressed from bortezomib with an alkylating agent (melphalan or cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or a glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or lenalidomide). The study will consist of a screening period, followed by up to eight open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, a follow-up period and maintenance cycles of single agent carfilzomib. Patient who complete the combination treatment period without progressive disease will be eligible for maintenance therapy with single-agent carfilzomib. During maintenance therapy carfilzomib will be administered at the same dose given during the last cycle of combination treatment.
The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.
To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.