Elranatamab for Multiple Myeloma
Recruiting in Palo Alto (17 mi)
+152 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Pfizer
Must be taking: Anti-CD38, Lenalidomide
Must not be taking: BCMA therapy, CD3 therapy
Disqualifiers: Smoldering MM, Plasma cell leukemia, Amyloidosis, others
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the study doctor to understand how your current treatments might interact with the trial.
What data supports the effectiveness of the drug Elranatamab for treating multiple myeloma?
Elranatamab has shown promising results in clinical trials for multiple myeloma, with a significant number of patients responding to the treatment. In the MagnetisMM-1 trial, 63.6% of patients experienced a positive response, and the drug demonstrated durable responses and manageable safety, offering hope for those with relapsed or refractory multiple myeloma.
12345Is Elranatamab safe for humans?
Elranatamab has been tested in clinical trials for multiple myeloma, and no dose-limiting toxicities (serious side effects that prevent increasing the dose) were observed. Some side effects included low blood cell counts and cytokine release syndrome (a reaction that can cause fever and flu-like symptoms), but overall, the safety was considered manageable.
12367What makes the drug Elranatamab unique for treating multiple myeloma?
Elranatamab is unique because it is a bispecific antibody that targets both BCMA on myeloma cells and CD3 on T cells, activating the T cells to attack the cancer cells. It is administered subcutaneously and has shown promising results in patients who have already undergone multiple other treatments, offering a new option for those with relapsed or refractory multiple myeloma.
12378Eligibility 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
You are not pregnant or breastfeeding and are okay with using birth control.
My last cancer treatment did not work according to IMWG standards.
My last cancer treatment did not work as expected.
+9 more
Exclusion Criteria
I do not have any ongoing serious infections.
I haven't had any cancer except for certain skin cancers or localized cancers that were treated, in the last 3 years.
I cannot undergo the standard treatment recommended by my doctor.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive elranatamab or a combination therapy until their MM is no longer responding
Up to approximately 5 years
Weekly visits initially, with potential reduction in frequency
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to approximately 35 days after last administration of study intervention
Telephone contacts or visits
Participant Groups
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:
Longs Peak HospitalLongmont, CO
The Moncton HospitalMoncton, Canada
WMCHealth Advanced Physician ServicesHawthorne, NY
Westchester Medical CenterValhalla, NY
More Trial Locations
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Who Is Running the Clinical Trial?
PfizerLead Sponsor
References
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.
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.
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.
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.
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).
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 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 .