Multiple myeloma trial

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR an autologous T cell product in combination with SEA-BCMA a monoclonal antibody in subjects with relapsed or refractory Multiple Myeloma. Maximum tolerated dose means the highest dose of a study drug that can be given with acceptable side effects. Recommended phase 2 dose means that dose is judged to be the most optimal for future study in patients with your disease.

The study will also examine how the body handles MT This will be done by looking at the pharmacokinetics of MTafter a single dose and after repeat doses in people Does Tai Chi Easy TCEasy , a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation? Patients will be given a 3 day course of chemotherapy followed by a single infusion of KITE The purpose of this study is to evaluate three different daratumumab dose schedules to treat participants who have Smoldering Multiple Myeloma.

This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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. The purpose of this study is to evaluate the safety and to determine the optimal dose of bb in subjects with high risk, HR newly -diagnosed multiple myeloma NDMM.

The purpose of this study is to test safety and anti-tumor activity of BT in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease. The purpose of this study is to determine the alterations in the intestinal microbiology in patients after undergoing chemotherapy, diet changes, and the use of antibiotics related to a stem cell transplant for Multiple Myeloma or Lymphoma; and how does this affect the success of the transplant and the patients long-term survival.

Open-label, sequential dose escalation and expansion study of CPI in patients with previously treated multiple myeloma. The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival PFS , compared to placebo, in patients with newly diagnosed multiple myeloma NDMM who have had a response complete response [CR], very good partial response [VGPR], or partial response [PR] to induction therapy followed by high-dose therapy HDT and autologous stem cell transplant ASCT.

The purpose of this study is to assess the safety, tolerability, and dose-limiting toxicities DLTs and to determine a recommended phase 2 dose regimen RP2DR defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR] of REGN as monotherapy in patients with relapsed or refractory multiple myeloma MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.

Prior clinical experience with CDtargeting antibodies, including daratumumab, establish this molecule as an important therapeutic target in multiple myeloma. CD38 is a type II transmembrane glycoprotein with both ectoenzymatic and signal transductionfunctions. CD38 dimerization is required for its catalytic activity Desphande et al, CDmediated cADPR generation enables calcium release from intracellular stores, leading to a variety of cell type-specific physiological outcomes Schuber and und, ; Lee and Aarhus, A distinct mode of CDdependent signal Characterize and identify the immune phenotype of patients with multiple myeloma by flow cytometry of peripheral blood circulating and bone marrow immune cells and by testing the immunogenticity of these cells in vitro.

Samples will be collected from patients longitudinally at baseline and post treatments to examine the effect of treatments on host immunity. The treatments include IMiDs, proteosome inhibitors, chemotherapy, monoclonal antibodies and stem cell transplantation. This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb in subjects with relapsed or refractory B cell maturation antigen BCMA -expressing multiple myeloma.

This phase II trial studies how well second mitochondrial-derived activator of caspases SMAC mimetic LCL alone or with cyclophosphamide works in treating patients with relapsed or refractory multiple myeloma. Biological therapies, such as SMAC mimetic LCL, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNBB, a T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy.

The study consists of 2 portions, a monotherapy dose escalation Arm A and a monotherapy dose expansion Arm B. Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNBB ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks Q3W , in approximately 24 subjects. Once the maximum tolerated dose MTD or Giving chemotherapy and total-body irradiation before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them.

The stem cells that were collected from the patient''s blood or bone marrow are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and total-body irradiation. The phase 1 primary objectives of this study are to assess the safety profile, characterize pharmacokinetics PK and determine the dosing schedule, maximum tolerated dose MTD , and recommended phase 2 dose RPTD of ABT venetoclax when administered in subjects with relapsed or refractory multiple myeloma.

This study will also assess the safety profile and PK of venetoclax in combination with dexamethasone in subjects with t 11;14 -positive multiple myeloma. The study will also assess patient perceived quality of life in connection to the use of intensive treatments. The purpose of this study is to evaluate the changes in bowel movements in patients with multiple myeloma receiving conditioning cheomotherapy for autologous stem cell transplantation SCT.

This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRFA in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRFA every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRFA for up to 17 cycles.

Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs. The purpose of this study is to investigate the safety and effectiveness of two doses of the antibody drug GSK in multiple myeloma patients who had 3 or more prior lines of treatment, are refractory to a proteasome inhibitor and an immunomodulatory agent and have failed an Anti-CD38 Antibody DREAMM 2. The purpose of this study is to evaluate quality of life over time in patients with multiple myeloma or lymphoma enrolled in clinical trials compared with patients on standard therapy.

The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant. To understand the mechanisms associated with diarrhea in patients receiving conditioning chemotherapy prior to autologous stem cell transplantation and to test the effects of the studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea associated with conditioning chemotherapy.

The purpose of this study is to determine how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement relapsed but is not resistant to bortezomib refractory. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

The purpose of this study is to measure subtle cognitive changes by using a simple and brief computer-based test CogState Battery in patients with Multiple Myeloma treated at Mayo Clinic in Scottsdale, Arizona.

The purpose of this study is to determine the maximum tolerated dose MTD , activity, and safety of oprozomib in patients with hematologic malignancies. Study PT, a multicenter, open-label dose-finding and pharmacokinetic study of PT in patients with relapsed or refractory multiple myeloma. This is designed as a two-part study. In the first part of the study, cohorts of three patients expanded to six patients in the event of a dose-limiting toxicity will receive escalating doses of PT until the MTD is reached, based on tolerability observed during the first 28 days of treatment.

In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of The purpose of this study is to explore how IMiD treatments affect certain genetic material called microRNAs in the body of patients with multiple myeloma.

Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, 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.

Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib and dexamethasone may be an effective treatment for multiple myeloma. This phase II trial studies how well pembrolizumab, lenalidomide, and dexamethasone work in treating patients with newly diagnosed multiple myeloma that are eligible for stem cell transplant.

Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, 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.

Giving pembrolizumab, lenalidomide, and dexamethasone may work better in treating patients with multiple myeloma. This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.

The purpose of this research study is to find out if the experimental treatment, ALLO in combination with ALLO, is safe and effective in treating multiple myeloma. The Phase 1 portion of this study will determine the safety of TAS and the most appropriate dose for patients with Multiple Myeloma or Lymphoma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Giving carfilzomib together with melphalan may kill more cancer cells. The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD] or are double refractory to a PI and an IMiD.

This study aims to demonstrate acceptability and feasibility of the use of Distance Reiki therapy versus sham Reiki therapy among multiple myeloma patients. The purpose of this study is to evaluate the overall minimal residual disease MRD negative rate of participants who receive JNJ The purpose of this study is to evaluate the clinical benefit of subcutaneous SC daratumumab administered in combination with standard multiple myeloma MM regimens in participants with MM as measured by overall response rate ORR or very good partial response VGPR or better rate.

This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.

The purpose of this study is to compare the effectiveness and safety of bb versus standard regimens in subjects with relapsed and refractory multiple myeloma RRMM. NCT view more. Jan 13, RRMM. Oct 15, RRMM. FORTE view more. Jan 12, NDMM. Jun 24, EHA Dec 20, RRMM.

Jul 1, All Trials a. CALGB Hovon IFM Marie was also responsible for the safety components in the following disciplines; Clinical Research, Medical Affairs and Clinical Education and Development. Pinizzotto received her B. She completed her residency at The Medical Center of Delaware, where she practiced obstetrics and gynecology for nine years. She still maintains privileges at the hospital. Most recently, Dr. Currently, Dr. In addition, she is a board member at Eisenhower Medical Center, Rancho Mirage, California, and also sits on the quality improvement committee.

Marie is named Chair, The Marie E. Pinizzotto is a director of The Carol A. From until , Dr. Parkinson served as President and CEO of Nodality, a South San Francisco-based venture-financed biotechnology company developing technologies to enable personalized medicine and more efficient drug development in cancer and autoimmune diseases. Before joining Nodality, Dr.

During his tenures at Amgen and Novartis, Dr. He received his M. CyberSource provides payment processing and other related services to online businesses. He was Chairman and CEO for 16 years. In July , Visa, Inc. McDougall is Partner at PricewaterhouseCoopers Health Sciences Practice, where he provides services to academic medical centers, bioscience companies, pharmaceutical companies, research universities, colleges, health systems, and other research organizations.

His practice provides a broad range of research business and compliance services, including strategic and business planning, financial analysis, research compliance, clinical research operations improvement, and information systems implementation services. In addition, his practice provides support services to the entire research continuum, from grant-funded basic science research, to translational research and clinical trials, including a dedicated group focusing on Clinical Research Consulting services.

Susan Marvin, Chair of the Board of The Marvin Companies, was part of the third-generation management team in what is today a fourth-generation family owned and operated company.

Prior to her current role, Susan was President of Marvin Windows and Doors where she oversaw the fenestration business. Susan is a graduate of the University of Minnesota where she earned an undergraduate degree in Journalism. David has played an integral role in launching, building and operating several successful companies in the life sciences.

In , he, along with Robert S. Langer at the Massachusetts Institute of Technology and other co-founders, started Frequency Therapeutics with the goal of developing regenerative medicines based on discoveries related to activating progenitor cells.

Prior to that, David co-founded, also with Dr. Langer, Semprus BioSciences. Semprus was acquired in by Teleflex, Inc. Prior to Semprus, David worked at the investment firm Polaris Partners.

He also serves as a trustee of Mt. David earned a B. Sloan Fellow. Earlier in his career, he was a bond trader and founded the Mortgage Finance Group. Rodney Gilmore is an attorney in the California Bay Area and a longtime college football broadcaster. He was nominated for an Emmy Award in for live sports coverage of Pac football. Following graduation from Stanford, he earned his law degree from the University of California at Berkeley Boalt Hall in , and was admitted to the California State Bar the same year.

Rodney specializes in transactional law with an emphasis on business formation and planning, mergers and acquisitions, and commercial transactions. He also has extensive experience in commercial real estate matters, including sales and acquisitions, financings and leases.

Gilmore is a longtime volunteer for Stanford. He is a member and former officer of two entities sponsored by the Stanford Alumni Association. He is also an active member of several Bar Associations and several local community organizations. Karen E. Andrews graduated cum laude from the University of Vermont with a Bachelor of Science degree in biology and earned her law degree, cum laude, from Temple School of Law.

In , Ms. Anderson graduated from Johns Hopkins Medical School. He trained in internal medicine at Johns Hopkins Hospital and completed hematology, medical oncology, and tumor immunology training at the Dana-Farber Cancer Institute. Lori Marcus is an independent board director and keynote speaker.

Lori is also the Chairman of the board of DNA Diagnostics Center, a growing leader in private DNA testing services, where she guides overall strategy and governance for corporate growth. Additionally, she is an independent Board Director for SHARE, a year-old survivor-led organization based in New York City that provides support, information, and resources to women affected by breast and ovarian cancers. Most recently, Ms. With more than 30 years of broad-based marketing and general management experience, Lori was responsible for global brand and product management for the Keurig system of innovative brewers and beverages.

Clinical trials and experimental therapies. Home Multiple Myeloma Treatment options Clinical trials and experimental therapies. Clinical trials. Here are a few things to know about clinical trials: Broadly, there are three types of clinical trials: Phase 1 trials determine safety and dosage, as well as how the drug is absorbed and acts in the body. Phase 2 trials evaluate effectiveness and safety. Phase 3 trials compare the effectiveness and safety of the new drug with those of standard treatments.

In addition to the new drugs currently being studied in clinical trials, drugs that have been previously approved to treat other diseases are being examined in clinical trials to determine whether they may be effective for treating multiple myeloma. Some patients worry that participating in a clinical trial may mean that they receive only a placebo and no actual treatment.

In fact, all patients in a clinical trial receive treatment; one set of patients receives standard treatment called the standard of care group and the other set of patients receives the new treatment called the new treatment group. Physicians and nurses who conduct clinical trials are always the most familiar with the latest research and treatments, and the trials often take place at larger research institutions.

If you decide to participate in a clinical trial, you will receive a consent form that serves as your guide to all of the important information you need to know about the trial.

In any clinical trial, you are allowed to quit at any point, for any reason. Find clinical trials. All drugs and therapies that have shown activity in multiple myeloma cells during laboratory studies must be studied in clinical trials before they are approved by the FDA for use in myeloma patients.

BCMA is a myeloma cell surface protein that is being used as a target for many different kinds of immunotherapies, because BCMA is found exclusively on myeloma cells. Get the latest myeloma news and updates. Sign up. We value your privacy. Contact Name. Register to speak to a myeloma mentor Contact Name.

Requested Mentor's Name:. Albumin level Higher levels may indicate better prognosis. Free light chain ratio MGUS: 0. Absence of abnormalities Gene expression profiling Presence of specific group of genes can predict low or high risk of early relapse. Personalize risk score. International Data Transfers Adequacy Decision: We may transfer your Personal Data to Switzerland and other countries which the European Commission has approved as providing adequate protection to personal data.

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Leadership and Corporate Connections For further inquiries on leadership and our strategic plan please fill out the below information. Company Website:. Total Employees:. Annual Revenue:. Have you read the Playbook? High Impact Topics Videos High impact topic videos, or HITs, are videos that use engaging animations and narration to present information on topics of importance to myeloma patients and their caregivers.

Genomics Hear how doctors can use genomic information from your myeloma cells to provide therapy that is tailored to your myeloma subtype. Learn Your Labs This video provides information on laboratory tests that myeloma patients may undergo. Learn about why and how the tests are done and what the results mean. Clinical Trials Discover how clinical trials work.

Multiple Myeloma Precursor Conditions Find out the difference between monoclonal gammopathy of undetermined significance MGUS and smoldering multiple myeloma SMM and what factors may put individuals with these conditions at higher risk for progressing to multiple myeloma.

Parmar, MD David H. Updates to the Disclosures Any changes to these Disclosures will be effective upon the earlier of thirty 30 calendar days following our dispatch of an email notice to you or thirty 30 calendar days following our posting of notice of the changes on the Website. Meryl Zausner Former Chief Financial Officer Novartis Corporation Meryl Zausner has over 35 years of management experience across the pharmaceutical and consumer products industries.

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