Teclistamab + Pomalidomide for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining two new drugs, teclistamab and pomalidomide, can better treat relapsed multiple myeloma compared to a standard treatment that includes carfilzomib. Teclistamab is a specialized antibody that targets and disrupts cancer cell growth, while pomalidomide enhances the immune system to combat cancer. Participants will be divided into different groups to compare these treatments. The trial seeks patients whose multiple myeloma has returned after previous treatments and who have already tried certain standard therapies. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have identified some safety concerns with teclistamab, such as infections and cytokine release syndrome (CRS), occurring in about 54% and 60% of patients, respectively. CRS can cause fever and flu-like symptoms. Despite these issues, many patients continued treatment without severe problems. Pomalidomide, when used in combinations, has been considered well-tolerated, with no major safety issues reported.
The FDA has already approved teclistamab for other uses, indicating it generally has an acceptable safety profile, though some risks remain. This trial is in its early stages, so the treatment's safety is still under study, but existing data provides some reassurance about its tolerability.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they incorporate teclistamab, a bispecific antibody that targets both BCMA and CD3, offering a novel approach compared to traditional treatments like lenalidomide and bortezomib. This unique mechanism allows the immune system to better identify and attack cancer cells. Additionally, teclistamab is administered subcutaneously, which may improve patient convenience and adherence compared to intravenous options. The combination with pomalidomide, an existing immunomodulatory drug, further enhances the potential to tackle multiple myeloma more effectively.
What evidence suggests that this trial's treatments could be effective for relapsed multiple myeloma?
This trial will evaluate the effectiveness of different treatment combinations for multiple myeloma. In one arm, patients will receive a combination of carfilzomib, pomalidomide, and dexamethasone. Studies have shown that using teclistamab with other drugs appears very promising for treating multiple myeloma, a type of blood cancer. In other arms of this trial, patients will receive teclistamab and pomalidomide. Teclistamab helps the immune system attack cancer by attaching to specific proteins on both the cancer cells and T-cells, a type of immune cell. Research shows that this combination can reduce the risk of disease progression or death by 83% when used with certain other treatments. Patients have responded well, with many experiencing complete responses and longer periods without disease worsening. Pomalidomide, when used with teclistamab, further boosts the immune system to effectively target cancer cells. Together, these drugs have the potential to improve outcomes for patients whose multiple myeloma has returned.24567
Who Is on the Research Team?
Murali Janakiram
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults (18+) with multiple myeloma that has come back after treatment. Participants must be able to perform daily activities, have certain lab findings like anemia or bone disease, and meet specific test results related to their cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either teclistamab and pomalidomide or carfilzomib, pomalidomide, and dexamethasone. Cycles repeat every 28 days for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Carfilzomib
- Dexamethasone
- Pomalidomide
- Teclistamab
Trial Overview
The study compares a new combination of teclistamab and pomalidomide against the usual treatment of carfilzomib, pomalidomide, and dexamethasone in people with relapsed multiple myeloma. Patients are randomly assigned to one of these groups.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Patients teclistamab SC on days 1, 4, 7, 14, and 21 of cycle 1, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, then on day 1 of subsequent cycles. Starting with cycle 2, patients receive pomalidomide PO QD on days 1-21 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo urine and blood sample collection, FDG PET/CT, and bone marrow biopsy and/or aspiration throughout the study.
Patients teclistamab SC on days 1, 4, 7, 14, and 21 of cycle 1, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, then on day 1 of remaining cycles. Starting with cycle 2, patients receive pomalidomide PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo urine and blood sample collection, FDG PET/CT, and bone marrow biopsy and/or aspiration throughout the study.
Patients receive carfilzomib IV on days 1, 2, 8, and 15 of cycle 1, on days 1, 8, and 15 of cycle 2, then on days 1 and 15 of subsequent cycles, pomalidomide PO QD on days 1-21 and dexamethasone PO or IV on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo urine and blood sample collection, FDG PET/CT, and bone marrow biopsy and/or aspiration throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Pomalidomide combinations are a safe and effective option ...
Results Responses improved from 37% with daratumumab to 53% with pomalidomide. Median progression-free survival and overall survival were 6 and ...
2.
targetedonc.com
targetedonc.com/view/teclistamab-plus-daratumumab-significantly-improves-survival-in-r-r-myelomaTeclistamab Plus Daratumumab Significantly Improves ...
The combination showed a higher complete response rate and MRD negativity, with a median PFS not reached, indicating superior efficacy.
Teclistamab plus Daratumumab in Relapsed or Refractory ...
Here, we report results with an 83% re- duction in the risk of disease progression or death. Progression-free survival benefits favored ...
4.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/495/530314/Teclistamab-Daratumumab-and-Pomalidomide-inTeclistamab, Daratumumab, and Pomalidomide in Patients ...
Overall response rate was 88.5%, very good partial response or better rate was 84.6%, and complete response or better rate was 61.5%. Median ...
FDA approves teclistamab
The major efficacy outcome measure was progression-free survival (PFS) Overall survival (OS) was an additional efficacy outcome measure. Median ...
6.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%202/LBA-6/556932/Phase-3-randomized-study-of-teclistamab-plusPhase 3 randomized study of teclistamab plus daratumumab ...
3/4 infections occurred in 54.1% and 43.4%. CRS rate was 60.1% (grade ・ with 83.4% of Tec-Dara pts alive ・ health outcomes of pomalidomide,
Unprecedented results from the Phase 3 MajesTEC ...
More than 90 percent of patients who were progression-free at six months (n=249) remained progression-free at three years.1. The study evaluated ...
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