New hope for myeloma: experimental drug takes on standard combo
NCT ID NCT07452198
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing a new drug called GR1803 against a standard three-drug combination (daratumumab, pomalidomide, and dexamethasone) in people with multiple myeloma that has come back after 1 to 3 prior treatments. About 358 participants will be randomly assigned to receive either GR1803 or the standard combo. The main goal is to see which treatment keeps the cancer from growing longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GR1803 injection (a drug given intravenously)
- What this could lead to
- If GR1803 works better than the current standard, it could offer a new treatment option for people with multiple myeloma that has come back after earlier therapies.
- What could go wrong
- This is an early Phase 3 trial, so results are not yet known. The new drug may not be more effective or could have unexpected side effects compared to the existing combination.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 358 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and baseline. * Diagnosed as multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG) diagnostic criteria. * Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. * Documented evidence of progressive or stable disease based on investigator's determination of response by IMWG criteria on or after their last regimen. * Measurable disease at screening and baseline as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 5 gram per liter (g/L); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=100 mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio. * Have clinical laboratory values within the specified range. * Have an understanding of and comply with the clinical trial protocol requirements, voluntarily participate in the clinical trial, and sign the informed consent form. Exclusion Criteria: * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or amyloidosis (including primary and secondary). * History or clinical signs of central nervous system involvement or meningeal involvement of multiple myeloma . * Received any prior B cell maturation antigen (BCMA)-directed therapy. * Has disease that is considered refractory or intolerant to an anti-cluster of differentiation 38 (CD38) targeted therapy or Pomalidomide. * Prior antitumor therapy, within 21 days (PI 、IMiDs or radiotherapy within 14 days, clinical trial vaccine within 28 days, Gene modified adoptive cell therapy within 3 months, allogeneic stem cell transplantation within 6 months, autologous stem cell transplantation within 12 weeks) prior to first dose of study drug. * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days prior to first dose of study drug. * Grade \>= 2 peripheral neuropathy at screening. * History of Guillain Barre Syndrome (GBS) or variant GBS. * The following medical conditions: active infecion, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, Syphilis infection, thromboembolic events or cerebrovascular events less than or equal to (\<=) 6 m, seizure attacks less than or equal to (\<=) 6 m. * Active malignancies other than relapsed/refractory multiple myeloma within 3 years prior to screening. * Active autoimmune disease or history of autoimmune disease. * Received a live, attenuated vaccine within 4 weeks before first dose of study drug. * Have major surgery within 2 weeks before first dose of study drug. * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. * Pregnant, lactating female.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITINGTianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas