Two new phase III clinical trials of isatuximab, an anti-CD38 monoclonal antibody, are enrolling myeloma patients. The IKEMA study assesses the clinical benefit of isatuximab combined with Kyprolis® and dexamethasone in patients with relapsed and/or refractory disease previously treated with one to three prior lines of therapy. The IMROZ study assesses the clinical benefit of isatuximab in combination with Velcade®, Revlimid®, and dexamethasone in patients with newly diagnosed myeloma not eligible for transplant.
IKEMA Clinical Trial Fact Sheet
clinicaltrials.gov Identifier: NCT03275285
A phase III, randomized, open-label, multicenter study assessing the clinical benefit of isatuximab combined with carfilzomib (Kyprolis®) and dexamethasone versus carfilzomib with dexamethasone in patients with relapsed and/or refractory multiple myeloma previously treated with 1 to 3 prior lines of therapy.
IMROZ Clinical Trial Fact Sheet
clinicaltrials.gov Identifier: NCT03319667
A phase III, randomized, open-label, multicenter study assessing the clinical benefit of isatuximab in combination with bortezomib (Velcade®), lenalidomide (Revlimid®), and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma not eligible for transplant.
Selinexor (KPT-330) is a first in class “Selective Inhibitor of Nuclear Export” (SINE) XPO1 antagonist, being developed by Karyopharm Therapeutics. It is currently being evaluated in multiple later stage clinical trials in patients with relapsed and/or refractory hematological and solid tumor malignancies. Click here to view how Selinexor works.
STORM Clinical trial Fact Sheet
clinicaltrials.gov Identifier: NCT02336815
Active, Not Recruiting
A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients with Multiple Myeloma Previously Treated with Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and Daratumumab, and Refractory to Prior Treatment with Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and the anti-CD38 mAb Daratumumab.
Watch the STORM trial updates video
BOSTON Clinical trial Fact Sheet
clinicaltrials.gov Identifier: NCT03110562
A Phase 3 Randomized, Controlled, Open-Label Study of Selinexor, Bortezomib (Velcade®), and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma.
clinicaltrials.gov Identifier: NCT02343042
A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma.
Watch the STOMP trial updates video
Carfilzomib (Kyprolis®) is the second drug to have been developed in a new class of drugs called proteasome inhibitors and approved by the US Food and Drug Administration (FDA). Proteasome inhibitors work by blocking the activity of enzyme complexes called proteasomes. Both normal cells and cancer cells contain proteasomes, which break down damaged and unwanted proteins into smaller components. Proteasomes also carry out the regulated breakdown of undamaged proteins in the cell, a process that is necessary for the control of many critical cellular functions. These smaller components are then used to create new proteins required by the cell. Proteasomes can be thought of as crucial to the cell’s “recycling” of proteins.
ARROW clinical trial fact sheet
Clinicaltrials.gov Identifier: NCT02412878
A Randomized, Open-label, Phase III Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib (Kyprolis®) in Combination with Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing
ENDEAVOR clinical trial fact sheet
ClinicalTrials.gov Identifier: NCT01568866
Phase III Study with Carfilzomib & Dexamethasone vs Velcade & Dexamethasone for Relapsed MM Patients.
Elotuzumab (Empliciti®) is a prescription medicine used to treat multiple myeloma in combination with the medicines Lenalidomide (Revlimid®) and Dexamethasone, in people who have received one to three prior treatments for their multiple myeloma.
ELOQUENT-1 Clinical trial fact sheet
ClinicalTrials.gov Identifier: NCT01335399
Active, Not Recruiting
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma.
ELOQUENT-2 clinical trial fact sheet
ClinicalTrials.gov Identifier: NCT01239797
Active, Not Recruiting
Phase III Randomized, Open-label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma.
Ixazomib (Ninlaro®) is a prescription medicine used to treat multiple myeloma in combination with the medicines Lenalidomide (Revlimid®) and Dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.
NCT02181413: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
In this phase III study, patients who have had any type of positive response to induction therapy followed by high-dose therapy with stem cell transplant will be randomly assigned by a computer to receive either a placebo (a capsule that looks like ixazomib but has no active ingredient) or ixazomib, an oral proteasome inhibitor, as maintenance therapy. This is a double-blind study, meaning that neither the patient, nor the caregiver, nor the doctor, nor those who evaluate the trial outcome know if the patient is receiving ixazomib or placebo.
NCT01850524: Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients with Newly Diagnosed Myeloma
A phase III multicenter study in which patients are randomly assigned by a computer to receive either a placebo (a capsule that looks like ixazomib but has no active ingredient) plus lenalidomide and dexamethasone, or ixazomib (an oral proteasome inhibitor) plus lenalidomide and dexamethasone. This is a double-blind study, meaning that neither the patient, nor the caregiver, nor the doctor, nor those who evaluate the trial outcome know which treatment regimen the patient is receiving. This trial is for patients with newly diagnosed myeloma who are not eligible for stem cell transplant.
NCT02046070: The Oral Combination of Ixazomib with Cyclophosphamide and Dexamethasone in Patients with Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma
A phase II trial for approximately 148 patients with either newly diagnosed or relapsed and/or refractory myeloma in which response rates and safety of the all-oral combination therapy of ixazomib (an oral proteasome inhibitor), cyclophosphamide (an alkylating chemotherapy agent), and dexamethasone (a synthetic steroid) will be assessed. Newly diagnosed patients will be randomly assigned by a computer to receive one of two different dosing regimens (only the dose of cyclophosphamide will vary), and relapsed/refractory patients will be assigned to a third group.