Multiple Myeloma study: Cohort A1 & A2: KTX-1001 vs KTX-1001+ pomalidomide
Official title A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05651932
What this study is testing
What is KTX-1001?
KTX-1001 is an investigational oral medicine being studied for relapsed or refractory multiple myeloma.
Also referred to as Dexamethasone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a small drug that blocks the MMSET protein is safe for adults with relapsed or refractory multiple myeloma.
- Who it's for
- You may be able to join if you have multiple myeloma that has come back or not responded to other treatments.
- What's involved
- You would take a pill every day and have a few blood tests to check safety. The study team will monitor you closely for side effects.
- Time commitment
- The study lasts about 6 months, with regular clinic visits and blood draws to track safety.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age
- ECOG score ≤ 1
- Multiple myeloma (as per IMWG)
- Prior therapy for MM: Participants must have received at least 1 and up to 3 prior lines of therapy as defined by IMWG, and the following drug...
- Participants must have a confirmed diagnosis of progressive MM (per IMWG), t(4;14) confirmed by fluorescence in situ hybridization (FISH) testing...
You likely can't join if
- Patients in Cohorts B1 and B2 must not have received prior mezigdomide treatment
- Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
- Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
- Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
- Cellular therapies ≤ 8 weeks
- Autologous transplant \< 100 days
See the full eligibility criteria
- ≥ 18 years of age
- ECOG score ≤ 1
- Multiple myeloma (as per IMWG)
- Prior therapy for MM: Participants must have received at least 1 and up to 3 prior lines of therapy as defined by IMWG, and the following drug classes: PI, IMiD, and anti-CD38 antibody.
- Participants must have a confirmed diagnosis of progressive MM (per IMWG), t(4;14) confirmed by fluorescence in situ hybridization (FISH) testing performed in a centralized Clinical Laboratory Improvement Amendments...
- Serum M protein ≥ 0.50 g/dL (by SPEP)
- Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
- Urine M protein ≥ 200 mg/24 h (by UPEP)
- sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
- Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
- Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only) Key
- Patients in Cohorts B1 and B2 must not have received prior mezigdomide treatment
- Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
- Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
- Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
- Cellular therapies ≤ 8 weeks
- Autologous transplant \< 100 days
- Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
- Major surgery ≤ 4 weeks
- Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic...
- Active CNS disease: participants with previously treated stable CNS disease are eligible, except for Cohorts B1 and B2 for which known CNS myeloma involvement is completely excluded.
- Inadequate bone marrow function
- Inadequate renal, hepatic, pulmonary, and cardiac function
- Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.
- Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 7 days or 5 half-lives (whichever is longer) prior to first dose
- Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
- Active malignancy not related to myeloma requiring therapy within \< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Tacoma, Washington, United States
- Toronto, Ontario, Canada
- Villeneuve-d'Ascq, France, France
- Nantes, France
- Poitiers, France
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Jacksonville, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Hackensack, New Jersey, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.