Elranatamab for Multiple Myeloma
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Pfizer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).
This study is seeking participants who:
* Are 18 years of age or older and have MM.
* Have received treatments before for MM.
* Have MM that has returned or not responded to their most recent treatment.
Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.
Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.
The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:
* a shot under the skin at the study clinic
* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.
Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).
The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
What data supports the idea that Elranatamab for Multiple Myeloma is an effective drug?The available research shows that Elranatamab is effective for treating multiple myeloma, especially in patients who have tried other treatments without success. In a study called the MagnetisMM-1 trial, 63.6% of patients responded positively to the drug, and 38.2% of them had a complete response, meaning their cancer was not detectable. The drug also helped patients live longer without their disease getting worse, with a median time of 11.8 months. Even for those who had tried similar treatments before, over half responded well to Elranatamab. This suggests that Elranatamab is a promising option for people with difficult-to-treat multiple myeloma.23568
Is the drug Elranatamab a promising treatment for multiple myeloma?Yes, Elranatamab is a promising drug for multiple myeloma. It has shown high response rates and long-lasting effects in patients who have tried other treatments without success. It works by helping the body's immune cells attack the cancer cells, and it has been approved in the USA for use in adults with relapsed or hard-to-treat multiple myeloma. Clinical trials have shown that many patients respond well to the drug, and it offers hope for improving outcomes in this challenging disease.45678
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received a live attenuated vaccine within 4 weeks of the first dose of the study intervention or have been treated with an investigational product within 30 days before starting the study.
What safety data is available for Elranatamab in treating multiple myeloma?Elranatamab, also known as ELREXFIO, has been evaluated for safety in clinical trials such as the MagnetisMM-1 phase 1 trial. In this trial, 88 patients with relapsed or refractory multiple myeloma received elranatamab, and no dose-limiting toxicities were observed during dose escalation. Adverse events included cytopenias and cytokine release syndrome, but the safety profile was considered manageable. The trial demonstrated durable responses and promising survival outcomes, indicating that elranatamab has a manageable safety profile for patients with multiple myeloma.15678
Eligibility Criteria
This trial is for adults with Multiple Myeloma (MM) that has returned or hasn't responded after treatment, including anti-CD38 antibody and lenalidomide. Participants must have had 1 to 4 prior MM treatments, meet specific lab value criteria, not be pregnant or breastfeeding, and agree to use contraception.Inclusion Criteria
My last cancer treatment did not work according to IMWG standards.
My last cancer treatment did not work as expected.
I can take care of myself and am up and about more than half of my waking hours.
I have multiple myeloma and have been treated 1-4 times, including with CD38 antibody and lenalidomide.
I can take care of myself but might not be able to do heavy physical work.
I have multiple myeloma and have been treated with 1-4 therapies, including CD38 antibody and lenalidomide.
Exclusion Criteria
I do not have any ongoing serious infections.
I cannot undergo the standard treatment recommended by my doctor.
My condition is smoldering multiple myeloma.
I have been diagnosed with POEMS syndrome.
My cancer has spread to my brain or spinal cord.
I have been diagnosed with plasma cell leukemia.
I have been diagnosed with amyloidosis.
I had a stem cell transplant less than 12 weeks ago or I have active graft versus host disease.
I have been treated with BCMA or CD3-targeting therapy before.
Treatment Details
The study compares elranatamab—a new medication given as a weekly shot—with a combination of standard MM therapies chosen by the doctor. The goal is to evaluate elranatamab's safety and effectiveness against these common treatments.
2Treatment groups
Experimental Treatment
Active Control
Group I: ElranatamabExperimental Treatment1 Intervention
Participants will receive elranatamab monotherapy
Group II: Investigator's ChoiceActive Control5 Interventions
Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
Elranatamab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Elrexfio for:
- Relapsed or refractory multiple myeloma
🇪🇺 Approved in European Union as Elrexfio for:
- Relapsed or refractory multiple myeloma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Infirmary Cancer CareMobile, AL
Longs Peak HospitalLongmont, CO
BRCR Global - TamaracTamarac, FL
Baylor Scott & White Medical Center - TempleTemple, TX
More Trial Locations
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Who is running the clinical trial?
PfizerLead Sponsor
References
Pooled analysis of the reports of carfilzomib, panobinostat, and elotuzumab combinations in patients with refractory/relapsed multiple myeloma. [2018]The purpose of this study was to better understand the efficacy and safety of carfilzomib, panobinostat, and elotuzumab combinations in patients with refractory/relapsed multiple myeloma(R/RMM).
New investigational drugs with single-agent activity in multiple myeloma. [2022]The treatment of multiple myeloma (MM) is rapidly evolving. In the United States, four drugs (panobinostat, ixazomib, daratumumab and elotuzumab) were approved for the treatment of MM in 2015. As a result of improved diagnosis and therapy, there has been a dramatic improvement in the outcome of MM in the last decade, probably more than any other malignancy. Numerous agents continue to be studied in preclinical models and in clinical trials, with many demonstrating clinical efficacy that appears promising enough to have a trajectory for regulatory approval. The purpose of this article is to summarize the current data and provide perspective on new investigational agents with promising single-agent activity in MM. The agents reviewed include Isatuximab, an anti-CD38 monoclonal antibody; marizomib, a new proteasome inhibitor; oprozomib, an oral proteasome inhibitor; filanesib (ARRY-520), a kinesin spindle protein inhibitor; dinaciclib, a cyclin-dependent kinase inhibitor; venetoclax (ABT-199), a selective BCL-2 inhibitor; and LGH-447, pan PIM kinase inhibitor.
A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. [2023]Treatment of patients with multiple myeloma (MM) in first relapse remains a challenge. This phase II study combined elotuzumab (Elo) with carfilzomib, lenalidomide, and dexamethasone (KRd) for treatment of MM in first relapse with the aim of improving efficacy.
Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. [2023]Elranatamab is a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody. In the ongoing phase 2 MagnetisMM-3 trial, patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses. After six cycles, persistent responders switched to biweekly dosing. Results from cohort A, which enrolled patients without prior BCMA-directed therapy (n = 123) are reported. The primary endpoint of confirmed objective response rate (ORR) by blinded independent central review was met with an ORR of 61.0% (75/123); 35.0% ≥complete response. Fifty responders switched to biweekly dosing, and 40 (80.0%) improved or maintained their response for ≥6 months. With a median follow-up of 14.7 months, median duration of response, progression-free survival and overall survival (secondary endpoints) have not been reached. Fifteen-month rates were 71.5%, 50.9% and 56.7%, respectively. Common adverse events (any grade; grade 3-4) included infections (69.9%, 39.8%), cytokine release syndrome (57.7%, 0%), anemia (48.8%, 37.4%), and neutropenia (48.8%, 48.8%). With biweekly dosing, grade 3-4 adverse events decreased from 58.6% to 46.6%. Elranatamab induced deep and durable responses with a manageable safety profile. Switching to biweekly dosing may improve long-term safety without compromising efficacy. ClinicalTrials.gov identifier: NCT04649359 .
Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. [2023]Multiple myeloma (MM) is a plasma cell malignancy expressing B cell maturation antigen (BCMA). Elranatamab, a bispecific antibody, engages BCMA on MM and CD3 on T cells. The MagnetisMM-1 trial evaluated its safety, pharmacokinetics and efficacy. Primary endpoints, including the incidence of dose-limiting toxicities as well as objective response rate (ORR) and duration of response (DOR), were met. Secondary efficacy endpoints included progression-free survival (PFS) and overall survival (OS). Eighty-eight patients with relapsed or refractory MM received elranatamab monotherapy, and 55 patients received elranatamab at efficacious doses. Patients had received a median of five prior regimens; 90.9% were triple-class refractory, 29.1% had high cytogenetic risk and 23.6% received prior BCMA-directed therapy. No dose-limiting toxicities were observed during dose escalation. Adverse events included cytopenias and cytokine release syndrome. Exposure was dose proportional. With a median follow-up of 12.0 months, the ORR was 63.6% and 38.2% of patients achieving complete response or better. For responders, the median DOR was 17.1 months. All 13 patients evaluable for minimal residual disease achieved negativity. Even after prior BCMA-directed therapy, 53.8% achieved response. For all 55 patients, median PFS was 11.8 months, and median OS was 21.2 months. Elranatamab achieved durable responses, manageable safety and promising survival for patients with MM. ClinicalTrials.gov Identifier: NCT03269136 .
Elrexfio™ (elranatamab-bcmm): The game-changer in treatment of multiple myeloma. [2023]Multiple myeloma is the second most common plasma cell malignancy, characterized by uncontrolled proliferation of plasma cells within the bone marrow. ELREXFIO™ (elranatamab-bcmm) is a recently FDA-approved drug for relapsed and refractory multiple myeloma. The progression of multiple myeloma involves interactions with various bone marrow cell types, and targeting this microenvironment has shown promising results in inhibiting its growth and osteolysis. ELREXFIO, a bispecific antibody targeting CD3 and BCMA, activates cytotoxic T-lymphocyte responses against BCMA-expressing myeloma cells. Clinical trials, such as MagnetisMM-3, demonstrated significant response rates and long-term tolerability. Its approval offers hope to multiple myeloma patients, especially those with relapsed or refractory cases, as innovative therapies like ELREXFIO continue to improve outcomes in this challenging malignancy.
Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: first reported case. [2023]Central nervous system (CNS) involvement in multiple myeloma (MM) is a rare and challenging complication associated with poor prognosis and limited treatment options. Emerging T-cell directing therapies, such as bispecific antibodies (bsAbs) and chimeric antigen receptor T cells (CAR-T), have shown remarkable success in treating MM, but their efficacy in CNS involvement remains unclear. Elranatamab, a humanized bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3-expressing T cells, has demonstrated promising results in relapsed refractory MM. However, its efficacy in treating CNS-MM has not been reported. We present a case of a 37-year-old male MM patient with CNS involvement who has been successfully treated with Elranatamab.
Elranatamab: First Approval. [2023]Elranatamab (elranatamab-bcmm; ELREXFIO™) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T cell engager being developed by Pfizer for the treatment of multiple myeloma (MM). Elranatamab bridges CD3 on T cells with BCMA expressed on multiple myeloma cells, thereby activating T cells to induce T cell-mediated cytotoxicity against myeloma cells. In August 2023, elranatamab received its first approval in the USA for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Elranatamab received accelerated approval for this indication based on response rate and durability of response, and continued approval may be contingent on the demonstration of clinical benefit in a confirmatory trial(s). Elranatamab has also received a positive opinion in the EU for RRMM and is under regulatory review in Japan and several other countries worldwide. Clinical studies of elranatamab are also underway in countries around the world. This article summarizes the milestones in the development of elranatamab leading to this first approval for the treatment of RRMM.