Daratumumab + Teclistamab for Plasma Cell Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments to determine which better helps people with plasma cell leukemia live longer. One group receives a combination of several drugs, including daratumumab, which aids the immune system in fighting cancer, and carfilzomib, which inhibits cancer cell growth. The other group receives teclistamab, a drug that may prevent cancer cells from spreading. The trial seeks participants diagnosed with plasma cell leukemia who show noticeable signs of the disease, such as high levels of certain proteins in their blood or urine. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have generally shown that teclistamab is well-tolerated by patients with multiple myeloma, a type of blood cancer. However, some side effects have been reported. A common side effect is cytokine release syndrome (CRS), which can cause fever and tiredness. In one study, most cases were mild, but a few were more severe. There is also a risk of serious, potentially life-threatening effects on the nervous system.
The other treatment option in this trial combines daratumumab with carfilzomib, lenalidomide, and dexamethasone. These treatments have been tested in other conditions and are already approved by the FDA for certain blood cancers, indicating some level of safety in humans, although specific side effects can vary.
Overall, both treatments show promise but come with risks. Prospective participants should discuss these risks with their doctor.12345Why are researchers excited about this trial's treatments?
Most treatments for plasma cell leukemia focus on controlling the cancer with medications like chemotherapy and targeted therapies. However, researchers are excited about combining Daratumumab and Teclistamab because they offer a new approach. Daratumumab is a monoclonal antibody that targets a protein on cancer cells called CD38, helping the immune system recognize and destroy them. Teclistamab is a bispecific antibody that binds to both cancer cells and immune cells, bringing them together to enhance the immune response against the cancer. This dual-action strategy could potentially improve effectiveness compared to standard treatments, offering hope for better outcomes.
What evidence suggests that this trial's treatments could be effective for plasma cell leukemia?
This trial will compare two treatment approaches for plasma cell leukemia. In one arm, participants will receive a combination of daratumumab, carfilzomib, lenalidomide, and dexamethasone (D-KRd). Research has shown that daratumumab, a monoclonal antibody, helps the immune system attack cancer cells by targeting a protein called CD38. Carfilzomib blocks parts of the cancer cells that aid their growth, causing the cells to die, while lenalidomide slows cancer cell growth and prevents the formation of blood vessels that tumors need to survive.
In the other arm, participants will receive teclistamab, another monoclonal antibody. Early research suggests that teclistamab can stop cancer cells from growing and spreading, showing promise in difficult-to-treat cases of multiple myeloma, with response rates up to 63%. Together, these treatments offer a comprehensive approach to fighting cancer cells in plasma cell leukemia.23467Who Is on the Research Team?
Douglas W Sborov
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with newly diagnosed plasma cell leukemia who are in good physical condition (able to care for themselves), have had little or no prior treatment, and agree to use effective birth control. Pregnant or nursing women cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants receive daratumumab, carfilzomib, lenalidomide, and dexamethasone over 4 cycles of 28 days each
Autologous Stem Cell Transplant
Participants undergo stem cell mobilization and collection followed by melphalan administration and autologous hematopoietic stem cell transplant
Consolidation Therapy
Participants receive either standard consolidation with D-KRd or teclistamab over 8 cycles of 28 days each
Maintenance Therapy
Participants receive carfilzomib and lenalidomide over 24 cycles of 28 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carfilzomib
- Daratumumab
- Dexamethasone
- Lenalidomide
- Teclistamab
Trial Overview
The study compares two treatments after stem cell transplant: one uses a combination of daratumumab, carfilzomib, lenalidomide, and dexamethasone; the other uses teclistamab alone. The goal is to see which approach helps patients with plasma cell leukemia live longer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
See Detailed Description.
See Detailed Description.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
The efficacy of teclistamab in patients with multiple myeloma ...
Long-term follow-up results of the MajesTec trial have shown promising efficacy of teclistamab in RRMM with overall response rate (ORR) of 63% and mPFS and mOS ...
2.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/tecvayli/medical-content/tecvayli-use-in-plasma-cell-leukemiaUse in Plasma Cell Leukemia - TECVAYLI®
A summary of clinical data regarding the use of TECVAYLI® (teclistamab-cqyv) in patients with plasma cell leukemia (PCL).
3.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/6994/526836/The-Efficacy-of-Teclistamab-in-Multiple-MyelomaThe Efficacy of Teclistamab in Multiple Myeloma Patients with ...
Overall response rate was 36% (4/11) and the best achieved response in this cohort of patients was a partial response (PR). The median time to ...
4.
targetedonc.com
targetedonc.com/view/real-world-analysis-shows-similar-safety-efficacy-with-teclistamab-in-rrmmReal-World Analysis Shows Similar Safety, Efficacy With ...
Median progression-free survival (PFS) was 5.4 months (95% CI, 3.4 months-not reached [NR]). At data cutoff, 29 patients died, with the ...
The Efficacy of Teclistamab in Multiple Myeloma Patients ...
In this case series we show that the efficacy of Tec in patients who developed sPCL was limited with no patient achieving a VGPR or better and ...
Safety and Efficacy of Teclistamab in Patients with ...
Even though most patients in our study did not meet the eligibility criteria for the MajesTEC-1 trial, teclistamab was safe and effective in this real-world ...
Side Effects & Safety Profile - TECVAYLI® (teclistamab-cqyv)
Find safety information for TECVAYLI® (teclistamab-cqyv), including warnings and precautions, adverse reactions, and more. See full Safety & Prescribing ...
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