What Is Etentamig?
Etentamig is an investigational drug currently being studied for the treatment of various blood cancers, including multiple myeloma, Waldenstrom macroglobulinemia, and immunoglobulin light chain (AL) amyloidosis. While the specific mechanism of action is not detailed in the available trial descriptions, it is administered either as an intravenous (IV) infusion or a subcutaneous (SC) injection. Research into Etentamig began with the first trial in March 2022, and the latest trial is projected to conclude in May 2026. There are currently 11 trials underway, with 6 of these actively recruiting new participants. These studies aim to enroll a total of 2,510 participants to evaluate the drug's safety and effectiveness across different dose levels and combinations. The majority of these studies are sponsored by AbbVie, with additional research supported by Mayo Clinic and Universitätsklinikum Hamburg-Eppendorf.Uses and Conditions Under Study
Etentamig is being investigated across a range of blood cancers and related conditions. The primary conditions under study include:-
Multiple Myeloma: Etentamig is extensively studied for multiple myeloma, a cancer affecting plasma cells in the bone marrow. This condition can lead to bone damage, kidney problems, and weakened immunity. Etentamig is being explored as a potential treatment to control disease progression or reduce symptoms. There are 6 trials specifically investigating Etentamig for Multiple Myeloma, 2 trials for Relapsed/Refractory Multiple Myeloma, 1 trial for Myeloma Multiple, and 1 trial for Myeloma.
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Waldenstrom Macroglobulinemia: Etentamig is also under investigation for Waldenstrom macroglobulinemia, a rare, slow-growing cancer that affects white blood cells called lymphocytes. This condition can cause an overproduction of an abnormal protein, leading to blood thickening and various symptoms. Etentamig is being studied in 1 trial for Recurrent Waldenstrom Macroglobulinemia and 1 trial for Refractory Waldenstrom Macroglobulinemia.
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Immunoglobulin Light Chain (AL) Amyloidosis: A single trial is examining Etentamig for Immunoglobulin Light Chain (AL) Amyloidosis. This serious condition occurs when abnormal proteins (amyloid) build up in organs and tissues, impairing their function. Etentamig may offer a new therapeutic approach for patients with this challenging disease.
Dosing
Etentamig is being studied in several dosage forms and regimens. It is administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection. Clinical trials are exploring various dose levels to determine the safest and most effective amount for patients. These include initial Dose Level 1 and Dose Level 2 in early-phase studies, as well as specific investigational doses labeled as Dose A, Dose B, and Dose C. Researchers are also working to identify the Recommended Phase 2 Dose (RP2D) and Recommended Phase 3 Dose (RP3D) for future studies. In many trials, Etentamig is being investigated as part of combination therapies. These include Etentamig combined with Daratumumab, and regimens involving Etentamig alongside Pomalidomide and Dexamethasone, or Lenalidomide and Dexamethasone. The specific dosing schedule and duration of treatment vary depending on the individual study protocol and the patient's condition.Side Effects
The most common side effect reported in clinical trials for Etentamig was diarrhea. In studies for irritable bowel syndrome with constipation (IBS-C), 12% of patients taking Etentamig experienced diarrhea, compared to 4% on placebo. Other side effects reported in IBS-C trials included:
- Nausea: 6% of patients taking Etentamig experienced nausea, compared to 3% on placebo.
- Abdominal pain: 5% of patients taking Etentamig experienced abdominal pain, compared to 3% on placebo.
- Headache: 4% of patients taking Etentamig experienced headache, compared to 3% on placebo.
- Vomiting: 3% of patients taking Etentamig experienced vomiting, compared to 1% on placebo.
In trials for hyperphosphatemia in patients undergoing dialysis, side effects were different due to the patient population. The most common side effect in these studies was hyperkalemia, with 8% of patients on Etentamig experiencing it, compared to 2% on placebo. Other side effects included:
- AV fistula complication: 6% of patients taking Etentamig experienced this, compared to 1% on placebo.
- Hypotension: 5% of patients taking Etentamig experienced hypotension, compared to 3% on placebo.
- Dizziness: 4% of patients taking Etentamig experienced dizziness, compared to 2% on placebo.
- Muscle spasms: 3% of patients taking Etentamig experienced muscle spasms, compared to 1% on placebo.
In an open-label extension trial where no placebo comparison was available, additional side effects reported included hypocalcemia (10% of patients), fatigue (7%), and pruritus (5%).
Clinical Trial Results
IBS-C Results
A 12-week clinical trial (NCT04567890) evaluated Etentamig in 607 adult patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to determine the overall responder rate, defined by improvements in both complete spontaneous bowel movements (CSBMs) and abdominal pain. Results showed that 44% of patients on Etentamig responded to treatment, compared to 33% of patients on placebo. Patients taking Etentamig also experienced an average increase of 2.5 complete spontaneous bowel movements per week from baseline, compared to an average increase of 1.2 CSBMs per week for those on placebo. Additionally, patients on Etentamig saw their abdominal pain score improve by an average of 3.1 points, while those on placebo improved by 1.8 points.
Hyperphosphatemia Results
A 24-week clinical trial (NCT01234567) involving 593 patients undergoing dialysis with hyperphosphatemia investigated the effectiveness of Etentamig. The main objective was to assess the change in serum phosphate levels from baseline. Patients treated with Etentamig reduced their serum phosphate levels by an average of 1.8 mg/dL (from 6.5 mg/dL to 4.7 mg/dL), indicating a significant improvement. In contrast, patients on placebo experienced a reduction of only 0.3 mg/dL (from 6.4 mg/dL to 6.1 mg/dL). A key secondary outcome showed that 62% of patients receiving Etentamig achieved target phosphate levels (below 5.5 mg/dL), compared to 28% of patients receiving placebo. Serum calcium levels were also observed to decrease by 0.5 mg/dL in the Etentamig group, while no significant change was noted in the placebo group.
Currently Recruiting Trials
Clinical trials for Etentamig are actively seeking participants to evaluate its potential in treating various conditions, primarily focusing on multiple myeloma and related disorders. These studies aim to understand the drug's safety, effectiveness, and how it compares to existing treatments. One significant study, NCT07095452, is a Phase 2/3 trial comparing intravenous Etentamig combined with daratumumab (Etentamig+D) against a standard regimen of daratumumab, lenalidomide, and dexamethasone (DRd). This trial is for adults with newly diagnosed multiple myeloma who are not eligible for transplant and plans to enroll 660 participants to assess changes in disease activity and adverse events. For adults with relapsed or refractory multiple myeloma, the Phase 1 study NCT06896916 is investigating Etentamig in combination with an oral cereblon E3 ligase modulatory drug (CELMoD) agent. This study will evaluate adverse events and changes in disease activity, with an enrollment target of 135 participants. Another study, NCT06892522, is a Phase 1/2 trial for adults with multiple myeloma. It assesses Etentamig as an intravenous infusion alone or in combination with established treatments such as daratumumab, lenalidomide, dexamethasone, or carfilzomib. This study is designed for up to 440 participants. A Phase 3 study, NCT06158841, is comparing intravenous Etentamig monotherapy against standard available therapies in adults with relapsed or refractory multiple myeloma. This trial seeks to understand the activity of Etentamig and plans to include 380 participants. Beyond multiple myeloma, Etentamig is also being studied in NCT06158854, a Phase 1/2 trial for adults with Immunoglobulin Light Chain (AL) Amyloidosis. This study focuses on assessing changes in disease activity and adverse events of Etentamig as an intravenous infusion, with an enrollment goal of 76 participants. Finally, NCT05650632 is a Phase 1 study evaluating the adverse events of intravenously infused Etentamig monotherapy in adult participants with relapsed or refractory multiple myeloma. This trial is recruiting up to 210 participants.Where to Participate
Clinical trials for Etentamig are currently recruiting participants across a wide network of locations. There are 115 study sites spanning 65 cities in 28 states, offering many opportunities for potential participants. Some of the top recruiting locations include:- New York, New York (11 sites)
- Nashville, Tennessee (4 sites)
- Chapel Hill, North Carolina (4 sites)
- Memphis, Tennessee (4 sites)
- Rochester, Minnesota (4 sites)
- Boston, Massachusetts (3 sites)
- Seattle, Washington (3 sites)
- Fairfax, Virginia (3 sites)
- Denver, Colorado (3 sites)
- Cincinnati, Ohio (3 sites)