Clinical Trials Fact Sheets

KTX-001

KTX-001 is an oral,first-in-class, selective MMSET catalytic inhibitor that suppresses H3k36me2 in patients with relapsed and refractory multiple myeloma

Study Protocol K36-MMSET-001
clinicaltrials.gov Identifier: NCT05651932

Active, Recruiting

KTX-1001 is an oral, first-in-class, selective MMSET catalytic inhibitor that suppresses H3k36me2 in patients with relapsed and refractory multiple myeloma (RRMM) with a focus on patients with the t(4;14 ) genetic translocation. This study will evaluate the safety, tolerability, and preliminary efficacy of KTX-1001. Available as well in SPANISH and FRENCH. 

Venetoclax

Venetoclax has already been approved to treat acute myeloid leukemia, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults and is now being evaluated to treat other types of cancers, including multiple myeloma. It is part of a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors that work by blocking the action of BCL-2 (a protein in the body that regulates cell death).

CANOVA Clinical Trial Fact Sheet
clinicaltrials.gov Identifier: NCT03539744

Active, Not Recruiting

The CANOVA study is a randomized, phase III, multi-center study using ventetoclax in subjects with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including lenalidomide and a proteasome inhibitor. This study will evaluate the safety and effectiveness of venetoclax plus dexamethasone compared with pomalidomide plus dexamethasone in approximately 122 patients in each study group.

Clinical Trial Fact Sheet
clinicaltrials.gov Identifier: NCT02899052

Active, Recruiting

This is a phase II, multi-center study using venetoclax in subjects with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This study will evaluate the safety and effectiveness of venetoclax in combination with carfilzomib and dexamethasone, compared with a standard treatment of carfilzomib and dexamethasone. This study will enroll 120 patients internationally.

Clinical Trial Fact Sheet
clinicaltrials.gov Identifier: NCT03314181

Active, Not Recruiting

This is a phase I/II, multi-center, dose-escalation study using venetoclax in subjects with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including an immunomodulatory agent. This study will evaluate the safety and effectiveness of venetoclax in combination with daratumumab, and dexamethasone at two dose levels, in comparison to daratumumab, bortezomib and dexamethasone. Approximately 104 patients will be enrolled internationally.

Isatuximab

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

Active, Not Recruiting

A phase III, randomized, open-label, multicenter study assessing the clinical benefit of isatuximab combined with Kyprolis® (carfilzomib) 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

Active, Not Recruiting

A phase III, randomized, open-label, multicenter study assessing the clinical benefit of isatuximab in combination with Velcade® (bortezomib), Revlimid® (lenalidomide), and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma not eligible for transplant.

Selinexor

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

Completed

A phase II b, open-label, single-arm Study of selinexor (KPT-330)  plus low-dose dexamethasone (Xd) 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.

BOSTON Clinical trial Fact Sheet
clinicaltrials.gov Identifier: NCT03110562

Active, Not Recruiting

A phase III randomized, controlled, open-label study of selinexor, bortezomib (Velcade®), and dexamethasone (XVd) versus bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma.

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STOMP Trial
clinicaltrials.gov Identifier: NCT02343042

Active, Recruiting

A phase 1b/2 study of selinexor (KPT-330) in combination with backbone treatments for relapsed/refractory multiple myeloma.

Kyprolis® (Carfilzomib)

Kyprolis® (carfilzomib) is the second drug to have been developed in a new class of drugs called proteasome inhibitors and approved by the U.S. 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

Completed

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

Completed

Phase III Study with carfilzomib and dexamethasone versus bortezomib and dexamethasone for relapsed multiple myeloma. 

Empliciti® (Elotuzumab)

Empliciti® (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines Revlimid® (lenalidomide) 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.

Ninlaro® (Ixazomib)

Ninlaro® (ixazomib) is a prescription medicine used to treat multiple myeloma in combination with the medicines Revlimid (lenalidomide)  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

Active, Not Recruiting

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.

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NCT01850524:  Ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone in adult patients with newly diagnosed myeloma

Active, Not Recruiting

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.

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NCT02046070: The oral combination of ixazomib with cyclophosphamide and dexamethasone in patients with newly diagnosed or relapsed and/or refractory multiple myeloma

Completed

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.

Read the Clinical Trial Fact Sheet:  English | Japanese | Korean | French