162 Participants NeededMy employer runs this trial

Teclistamab + Pomalidomide for Multiple Myeloma

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Cancer Institute (NCI)
Must be taking: Immunomodulatory drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MJ

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

I have at least 10% plasma cells in my bone marrow or a confirmed plasmacytoma.
I am 18 years old or older.
* Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay for Phase II only
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either teclistamab and pomalidomide or carfilzomib, pomalidomide, and dexamethasone. Cycles repeat every 28 days for up to 2 years.

Up to 2 years
Multiple visits per cycle, including days 1, 4, 7, 14, 21 for teclistamab and days 1, 2, 8, 15 for carfilzomib

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 10 years
Every 3 months for up to year 2, every 6 months for years 2-5, then yearly

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

Group I: Arms C (teclistamab, pomalidomide)Experimental Treatment8 Interventions
Group II: Arms A and B (teclistamab, pomalidomide)Experimental Treatment7 Interventions
Group III: Arm D (carfilzomib, pomalidomide, dexamethasone)Active Control9 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

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 ...

Teclistamab 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 ...

Teclistamab, 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 ...

Phase 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 ...