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Compares treatment options for Multiple Myeloma
Official title A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07452198
What this study is testing
What is GR1803 injection?
GR1803 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Documented evidence of progressive or stable disease based on investigator's determination of response by IMWG criteria on or after their last...
- 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...
You likely can't join if
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or...
- 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...
- Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days prior to first dose of study drug.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.