Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called talquetamab (the study drug) for people with relapsed/refractory multiple myeloma. We want to compare how the study drug works on its own to how it works in combination with different drugs.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with MM that is not improving with treatment or has come back after treatment</li>
<li>Have received previous treatment with a proteasome inhibitor, an immunomodulatory, and an anti-CD38 monoclonal antibody</li></ul>
For more information about who can join this study, please contact the study team at 919-668-2556.
<li>Are diagnosed with MM that is not improving with treatment or has come back after treatment</li>
<li>Have received previous treatment with a proteasome inhibitor, an immunomodulatory, and an anti-CD38 monoclonal antibody</li></ul>
For more information about who can join this study, please contact the study team at 919-668-2556.
What is Involved?
If you decide to participate in this study, you will start a study drug regimen in the following manner:
<ul>
<li>You will take the study drug over the course of 28-day periods called "cycles"</li>
<li>During your first cycle, you will get 3 small doses of the study drug 2-4 days apart as a ramp-up to getting a full dose of the study drug on the 15th day of your first cycle.</li>
<li>For every cycle after your first, you will get the study drug on the 1st and 15th days of each cycle (every 2 weeks).</li>
<li>If you have a good response to the study drug for the first 4 cycles, the study doctor might choose to only give you 1 dose rather than 2 per cycle.</li></ul>
Before you begin taking the study drug, you will get a random assignment (fair, equal chance) to 1 of 4 groups.
<ul>
<li>Group A: If you are in this group, you will take only the study drug.</li>
<li>Group B: If you are in this group, you will use dexamethasone mouthwash every day for as long as you are taking the study drug.</li>
<li>Group C: If you are in this group, you will take a 50 mg capsule of a drug called pregabalin twice each day for as long as you are taking the study drug.</li>
<li>Group D: If you are in this group, you will take a 0.5 mg tablet of a drug called clonazepma twice each day for as long as you are taking the study drug.</li></ul>
The following tests and procedures will be performed throughout the study:
<ul>
<li>Physical exams</li>
<li>Electrocardiogram (ECG), a recording of the electrical activity of your heart</li>
<li>Blood samples</li>
<li>Potential nutritional consultation</li>
<li>Neurological exam</li>
<li>Imaging tests (CT, PET/CT and MRI) </li>
<li>Bone marrow biopsy</li>
<li>Tongue swabs</li>
<li>Questionnaires</li>
<li>Salivary flow test</li>
<li>Smell assessments</li>
<li>Qualitative interviews</li></ul>
<ul>
<li>You will take the study drug over the course of 28-day periods called "cycles"</li>
<li>During your first cycle, you will get 3 small doses of the study drug 2-4 days apart as a ramp-up to getting a full dose of the study drug on the 15th day of your first cycle.</li>
<li>For every cycle after your first, you will get the study drug on the 1st and 15th days of each cycle (every 2 weeks).</li>
<li>If you have a good response to the study drug for the first 4 cycles, the study doctor might choose to only give you 1 dose rather than 2 per cycle.</li></ul>
Before you begin taking the study drug, you will get a random assignment (fair, equal chance) to 1 of 4 groups.
<ul>
<li>Group A: If you are in this group, you will take only the study drug.</li>
<li>Group B: If you are in this group, you will use dexamethasone mouthwash every day for as long as you are taking the study drug.</li>
<li>Group C: If you are in this group, you will take a 50 mg capsule of a drug called pregabalin twice each day for as long as you are taking the study drug.</li>
<li>Group D: If you are in this group, you will take a 0.5 mg tablet of a drug called clonazepma twice each day for as long as you are taking the study drug.</li></ul>
The following tests and procedures will be performed throughout the study:
<ul>
<li>Physical exams</li>
<li>Electrocardiogram (ECG), a recording of the electrical activity of your heart</li>
<li>Blood samples</li>
<li>Potential nutritional consultation</li>
<li>Neurological exam</li>
<li>Imaging tests (CT, PET/CT and MRI) </li>
<li>Bone marrow biopsy</li>
<li>Tongue swabs</li>
<li>Questionnaires</li>
<li>Salivary flow test</li>
<li>Smell assessments</li>
<li>Qualitative interviews</li></ul>
Study Details
Full Title
A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on
Talquetamab-related Oral Toxicity
Talquetamab-related Oral Toxicity
Principal Investigator
Yubin
Kang
Protocol Number
PRO00115711
NCT ID
NCT06500884
Phase
II
Enrollment Status
Pending Open to Enrollment