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Compares treatment options for Multiple Myeloma
Official title A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
ClinicalTrials.gov ID: NCT07095452
What this study is testing
What is Etentamig?
Etentamig is an investigational medicine, given as an injection under the skin, 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
- Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure.
- 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
- Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic...
- IMWG Myeloma Frailty Index Score of \>= 1
- All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
- Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
- Urine M-protein \>= 200 mg/24 hours.
You likely can't join if
- Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of...
- Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose...
- Participant who has known active central nervous system involvement of MM.
- Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic...
See the full eligibility criteria
- Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to...
- IMWG Myeloma Frailty Index Score of \>= 1
- All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
- Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
- Urine M-protein \>= 200 mg/24 hours.
- Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
- Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
- Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
- Participant who has known active central nervous system involvement of MM.
- Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Atlanta, Georgia, United States
- Fort Wayne, Indiana, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Eugene, Oregon, United States
- Nashville, Tennessee, United States
- The Woodlands, Texas, United States
- Tyler, Texas, United States
- Fairfax, Virginia, United States
- Roanoke, Virginia, United States
- Epagny Metz Tessy, Auvergne-Rhône-Alpes, France
- Dunkirk, Hauts-de-France, France
- Lille, Hauts-de-France, France
- Montpellier, Herault, France
- Tours, Indre-et-Loire, France
+ 24 more site(s).
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 Scottsdale, Arizona, United States; Los Angeles, California, United States; Denver, Colorado, United States; Atlanta, Georgia, United States; Fort Wayne, Indiana, United States; Minneapolis, Minnesota, United States and 38 more location(s). 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.