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An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06158854

Population:

Adult

Phase:

I

The purpose of this study is to see how safe and effective is the study drug, ABBV-383. ABBV-383 works by binding to a specific protein called B-cell maturation antigen, which is found on the surface of cells affected by amyloidosis. By engaging T-cells, a type of white blood cell, ABBV-383 helps activate the immune response to target and remove the abnormal proteins that cause amyloidosis. The study drug ABBV-383, is not approved by the U.S Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Must consent to fresh pretreatment bone marrow...
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05451771

Population:

Adult

Phase:

I/II

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and dexamethasone versus investigator’s choice treatment in this condition. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Can you comply with the procedures in this study, which include taking the study drug and extra clinic...
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...
A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06022939

Population:

Adult

Phase:

III

This study is being done to answer the following questions: • Do people with amyloid light chain (AL) amyloidosis respond better to a consolidation treatment that uses either one high dose of the drug melphalan plus stem cell transplant or more chemotherapy alone? • Which treatment plan gives patients a better quality of life? To determine which treatment plan works better against AL amyloidosis, the study is set up to find out how good the treatments are at lowering the chance of AL amyloidosis causing problems in major organs of the body. The researchers will compare the results...
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...
A Phase III Randomized Trial For Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail Or In A Subset of “Intermediate Fit” Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT05561387

Population:

Adult

Phase:

III

The purpose of this study is to compare the usual treatment plan to using a different combination of drugs. Researchers will test a different combination of drugs called DRd. DRd combines 3 drugs for treatment: daratumumab and hyaluronidase, lenalidomide, and dexamethasone. Using the study treatment instead of the usual treatment could reduce or control the cancer better. The study treatment may also cause side effects which the doctors will be watching for. This study will help the study doctors learn which combination of drugs is better among the usual treatments for multiple myeloma...
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...
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 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...
MRD-GUIDED SEQUENTIAL THERAPY FOR DEEP RESPONSE IN NEWLY DIAGNOSED MULTIPLE MYELOMA - MASTER-2 TRIAL

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05231629

Population:

Adult

Phase:

II

The purpose of the study is to determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who are MRD “positive” at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD “negative” with autologous hematopoietic cell transplantation (AHCT) plus a new immunotherapy called teclistamab in combination with...

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