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PHASE 1/2 FIH STUDY OF REGN5458 (ANTI-BCMA X ANTI-CD3BISPECIFIC ANTIBODY) IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT03761108

Population:

Adult

Phase:

I/II

This study will look at the safety of a drug (REGN5458) in patients with multiple myeloma. It will also try to find out what the best dose of REGN5458 is and look for any signs that REGN5458 can help treat your cancer. REGN5458 is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) for any condition. Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Have you been diagnosed with Multiple Myeloma? Has your disease progressed?
MajesTEC-9: A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT05572515

Population:

Adult

Phase:

III

The purpose of this study is to see how teclistamab by itself compares to study treatment combinations that are commonly used to treat multiple myeloma. These study treatment combinations are either pomalidomide, bortezomib and dexamethasone, called PVd, or carfilzomib and dexamethasone, called Kd. The patients will be randomly assigned to on of the study groups. The term randomized means something is done by chance or without any particular pattern, like flipping a coin to decide an outcome. Are you Eligible? (Inclusion Criteria) Are you at least 18 years of age or older? - Do you have a...
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT05827016

Population:

Adult

Phase:

III

The purpose of the study is to test the safety and efficacy of iberdomide in a larger number of patients. Iberdomide is not FDA approved for the treatment of any disease. This study will also assess how patients feel about the multiple myeloma treatment received in this study, and their quality of life as it relates to their health. Iberdomide is a medication taken by mouth that binds to a protein known as cereblon, which may result in the destruction of specific proteins by the body. This study drug may modify or regulate the functioning of the immune system and may induce the destruction of...
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT03937635

Population:

Adult

Phase:

III

The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups. Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at...
R5458-ONC-2012:PHASE 1B STUDY OF REGN5458 (ANTI-BCMA X ANTICD3 BISPECIFIC ANTIBODY) PLUS OTHER CANCER TREATMENTS FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05137054

Population:

Adult

Phase:

I

This study is the first time REGN5458 will be combined with other cancer therapies. The main goal is to understand if REGN5458 can be given safely with other cancer study treatments, and if so, what dose of REGN5458 should be used for each combination. The investigational drug, REGN5458, is not approved by the Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18 years of age? - Are you likely to live for at least six more months? -Do you have measurable disease as defined in the protocol according to International Myeloma Working Group (IMWG)...
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants with Relapsed and/or RefractoryMultiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT06121843

Population:

Adult

Phase:

I

The purpose of this study is to test whether BMS-986393 in combination with other anti- cancer drugs is safe and effective at treating people with multiple myeloma (MM) that has come back after previous treatment (relapsed) or is not responding to current treatment (refractory). The researchers think that the combinations of alnuctamab, mezigdomide, or iberdomide with BMS-986393 in people with relapsed/refractory MM may improve their disease or keep their disease under control. This is an open-label, multicenter study that will recruit potential participants in the United States (USA) and...
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd)followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) TherapyDirected Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd)

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT04923893

Population:

Adult

Phase:

III

The purpose of this study is to see if Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by cilta-cel is safe and useful for treating patients with newly diagnosed Multiple Myeloma, as compared with the use of VRd followed by Lenalidomide and Dexamethasone (Rd) therapy. Cilta-cel is a CAR-T cell therapy. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become cilta-cel and used to treat your multiple myeloma. After pre-randomization therapy you will be assigned randomly into either Arm A or Arm B of the study. If...
A SINGLE ARM, MULTICENTER, PHASE II, OPEN-LABEL TRIAL TO EVALUATE EFFICACY OF ISATUXIMAB IN PATIENTS WITH MONOCLONAL GAMMOPATHY OF RENAL SIGNIFICANCE

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT04614558

Population:

Adult

Phase:

II

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with Monoclonal Gammopathy of Renal Significance (MGRS). Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treatMonoclonal Gammopathy of Renal Significance (MGRS). This means that the use of isatuximab in this study is considered ‘investigational’. Are you Eligible? (Inclusion Criteria) • Are you 18 years of age or older? • Do you have persistent renal...
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT04504825

Population:

Adult

Phase:

III

The purpose of the study is to determine if the drug, CAEL-101 in combination with plasma cell treatment improves overall survival for patients who are diagnosed with stage 3b of AL amyloidosis. Patients who participate in this study will receive CAEL-101 as well as plasma cell treatment or Placebo as well as plasma cell treatment to compare the effects. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Are you diagnosed with stage 3b of AL amyloidosis? Have you not receive treatment for your disease?
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT04973137

Population:

Adult

Phase:

III

The purpose of this study is to evaluate whether birtamimab plus standard of care will improve survival in subjects with Mayo Stage IV AL amyloidosis. Birtamimab has not yet been approved by the Food and Drug Administration (FDA). During the first phase of the study, the purpose of this study is to evaluate whether birtamimab plus standard of care will improve survival in subjects with Mayo Stage IV AL amyloidosis. For the first phase of the study where neither the researchers nor the study subjects know who is getting the experimental treatment and who is getting a placebo (the double-blind...

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