Our treatment approach emphasizes the translation of scientific discovery to clinical applications. We have a robust program of clinical trials, under the leadership of Ajai Chari, MD, that enable patients to benefit from innovative and advanced treatment options.
Clinical trials, also known as clinical research protocols, let us test new treatments in a safe, structured manner and collect data that enables statistically valid analysis. They are instrumental in advancing approval of new drugs that are beneficial to patients. Many new drugs have been approved for myeloma recently, including four in 2015 alone. Our research program has played a pivotal role in approval by the U.S. Food and Drug Administration (FDA) of many of these new drugs, including Carfilzomib, Pomalidomide, Elotuzamab, Daratumamab, and Ixazomib. We would not have been able to achieve this progress without patient participation in clinical trials.
Many questions remain about the causes of myeloma, sequencing and mechanisms of resistance to therapies, and personalization of treatment. Clinical trials can help answer these questions. We are also looking tirelessly to develop new options for patients who have exhausted currently available therapies.
Depending on the stage of your disease, exposure to prior therapies, and overall health, you may be eligible to participate in a clinical trial. Your doctor will determine whether you are a candidate for a clinical trial and are likely to benefit from it. If you are eligible for a trial, we will talk with you about the “Informed Consent” form, which describes the study and its potential benefits and safety concerns. You will have time to review this document at home, and we will answer any questions you may have as you decide if you want to participate. Some of our clinical trials are only open to patients at Mount Sinai. With our large patient volume, these “investigator-initiated” trials can enroll enough patients for statistically valid data.
We also conduct studies together with pharmaceutical companies that are developing new drugs based on our findings as well as discoveries from other laboratories. For example, we are participating in Celgene’s Chimeric Antigen Receptor (CAR)-T cell clinical trial, an innovative immunotherapy approach with promising results to date. (In this study, T-cells from myeloma patients are genetically engineered to recognize a protein known as B-cell maturation antigen (BCMA) found on malignant plasma cells. Once injected back into the patient, these altered T-cells seek out and kill BCMA-containing cells.)
In some cases, clinical trials are conducted at multiple centers (such as the CoMMpass study with the Multiple Myeloma Research Foundation). This approach enables more patients to participate and helps us more quickly gather the statistical results necessary to gain FDA approval of new drugs.
Our complete list of clinical trials includes trials that are open to patient enrollment as well as those that are no longer open to enrollment but that are following participating patients. The following clinical trials are open for participation:
Smoldering Multiple Myeloma
- A Phase 2 Study of the Effect of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib on Disease Response in Patients With High Risk Smoldering Multiple Myeloma
ClinicalTrials.gov Identifier: NCT02943473
Newly Diagnosed Multiple Myeloma
- Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation
ClinicalTrials.gov Identifier: NCT02874742
Newly Diagnosed (Less than 3 cycles of treatment) Multiple Myeloma
- Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)
ClinicalTrials.gov Identifier: NCT02728102
Stem Cell Transplant Maintenance
- A Phase 1, Multicenter, Open-label, Safety Study of Human Cord Blood Derived, Culture-expanded, Natural Killer Cell (PNK-007) Infusion Following Autologous Stem Cell Transplant for Multiple Myeloma
ClinicalTrials.gov Identifier: NCT02955550
- A Phase II Study of IRD (Ixazomib, Lenalidomide, and Dexamethasone) for Consolidation Therapy Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
- A Multicenter Phase 1/2b of the Bruton’s Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis) in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma
ClinicalTrials.gov Identifier: NCT01962792
- A Phase I Study of the Combination of a Selective Inhibitor of Nuclear Export, Selinexor, with Carfilzomib and Dexamethasone in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov Identifier: NCT02199665
- A Phase 2b, Open-Label, Single-Arm Study Of Selinexor (KPT-330) Plus Low-Dose Dexamethasone In Patients With Multiple Myeloma Refractory To Bortezomib, Lenalidomide, Carfilzomib And Pomalidomide
ClinicalTrials.gov Identifier: NCT02336815
- A Phase 1a/1b, Multi-center, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma.
- Oral ONC201 in Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov Identifier: NCT02863991
- A Phase 1b Study of SAR65098 (Anti-CD38 mAb) in Combination with Carfilzomib for the Treatment of Relapsed or Refractory Multiple Myelom
ClinicalTrials.gov Identifier: NCT01084252
- A Phase 1/2, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
- Open-label, Multicenter, Dose-escalation/Expansion Phase Ib Study to Evaluate Safety, Pharmacokinetics, and Activity of BET Inhibitor RO6870810, Given as Mono- and Combination Therapy to Patients with Advanced Multiple Myeloma
ClinicalTrials.gov Identifier: NCT03068351
Immunotherapy for Relapsing/Refractory Myeloma
- A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma