Monoclonal Antibody and Stem Cell Transplant for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find new treatments for individuals diagnosed with high-risk multiple myeloma, a type of blood cancer. Researchers are testing various combinations of monoclonal antibody therapies, designed to enhance the immune system's ability to fight cancer cells. The study includes both a standard treatment group and an experimental group with new therapy combinations, including bispecific monoclonal antibodies. Individuals recently diagnosed with high-risk multiple myeloma and experiencing symptoms that affect daily life may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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 your specific situation with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that linvoseltamab, a type of specialized antibody, is generally safe for patients with relapsed or refractory multiple myeloma. Studies have found that most side effects are mild and manageable. Early trials, for instance, indicate that linvoseltamab has a good safety record and effective results, with many patients responding well to the treatment.
Although linvoseltamab is not yet approved for all uses, ongoing trials are crucial to confirm its safety and effectiveness. Prospective participants should consider this information as suggesting that linvoseltamab is generally safe, but discussing any concerns with a doctor is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they introduce innovative approaches to tackling this challenging cancer. Unlike traditional treatments like chemotherapy and radiation, which broadly attack cancer cells, bispecific monoclonal antibodies and the use of Linvoseltamab in combination therapy offer a more targeted attack. Bispecific monoclonal antibodies can simultaneously bind to both cancer cells and immune cells, enhancing the immune system's ability to destroy the cancer. Linvoseltamab, when used with triplet therapy, leverages a combination approach that aims to improve outcomes by attacking the cancer from multiple angles. These cutting-edge therapies hold the promise of increasing effectiveness and potentially reducing side effects compared to existing treatments.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Studies have shown that linvoseltamab, a monoclonal antibody, effectively treats multiple myeloma, a type of blood cancer. In past research, 71% of patients treated with linvoseltamab experienced tumor reduction or disappearance. This treatment also achieved minimal residual disease (MRD) negativity, indicating a deep and lasting response. Linvoseltamab has shown promise even for patients unresponsive to previous treatments. In this trial, participants will receive either the control treatment of Isa-KRd with Autologous Stem Cell Transplant or the experimental treatment combining Linvoseltamab and triplet therapy. These findings suggest Linvoseltamab could be effective for people with high-risk multiple myeloma.34678
Who Is on the Research Team?
Hearn Jay Cho, MD, PhD
Principal Investigator
Multiple Myeloma Research Foundation
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have just been diagnosed with high-risk multiple myeloma, based on specific genetic changes or lab results. Participants must not have had more than two cycles of standard treatment and need to be able to give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive investigational therapies or control treatment as per the assigned arm, including induction, consolidation, and maintenance therapy
Follow-up
Participants are monitored for safety, effectiveness, and overall survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bispecific Monoclonal Antibody
- Monoclonal Antibody
Trial Overview
The study compares several new treatments for high-risk multiple myeloma, including monoclonal antibodies combined with stem cell transplant, bispecific antibodies, and triplet therapy. Patients are randomly assigned to different groups in this adaptive platform trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Appendix B to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy in Patients with High Risk Newly Diagnosed Multiple Myeloma
Appendix A to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Isa-KRd with Autologous Stem Cell Transplant in Patients with High Risk Newly Diagnosed Multiple Myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Multiple Myeloma Research Consortium
Lead Sponsor
Citations
Effectiveness of linvoseltamab versus real-world standard ...
Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Leukemia. 2019;33:2266–75. Article CAS ...
2.
onclive.com
onclive.com/view/linvoseltamab-adds-highly-effective-option-in-later-line-multiple-myelomaLinvoseltamab Adds Highly Effective Option in Later-Line ...
Data from LINKER-MM1 revealed that patients who received the BCMA-directed CD3 T-cell engager (n = 80) experienced an objective response rate ( ...
3.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(25)04283-1/fulltextLinvoseltamab in Patients With Relapsed/Refractory ...
Median progression-free survival was not reached, and median overall survival was 31.4 months. Minimal residual disease negativity (10−5 threshold) was achieved ...
4.
investor.regeneron.com
investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-monotherapy-newly-diagnosed-multipleLynozyfic™ (linvoseltamab) Monotherapy in Newly ...
Lynozyfic monotherapy is already achieving MRD negativity rates comparable to quadruplet regimens but earlier in the treatment course, and these ...
Linvoseltamab for Treatment of Relapsed/Refractory Multiple ...
Among the 117 patients treated with 200 mg, the median age was 70 years, 39% had high-risk cytogenetics, and 28% had penta-refractory disease.
6.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/2254/549556/Safety-and-efficacy-of-linvoseltamab-LINVOSafety and efficacy of linvoseltamab (LINVO) combined with ...
Of 10 MRD-evaluable pts, all were MRD negative (<10−5by clonoSEQ or EuroFlow). The 12-mo DOR rate was 79% (95% confidence interval [CI] 52–92; ...
Safety and efficacy of linvoseltamab (LINVO) combined ...
Combining LINVO with an anti-CD38 mAb, such as DARA or ISA, may provide additional benefit to pts with RRMM. Here we report pooled safety and efficacy results ...
8.
ashpublications.org
ashpublications.org/ashclinicalnews/news/9240/Linvoseltamab-in-R-R-MM-Linked-to-Improved-HealthLinvoseltamab in R/R MM Linked to Improved Health-Related ...
At a median of 21.3 months follow-up, the previously reported efficiency and safety results showed that treatment with linvoseltamab 200 mg ...
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