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Compares treatment options for Multiple Myeloma
Official title Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06158841
What this study is testing
What is Etentamig?
Etentamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as ABBV-383.
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
- Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
- Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
- Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
- Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
- Urine M-protein \>= 200 mg/24 hours.
You likely can't join if
- Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
- Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic...
- Central nervous system involvement of MM.
- Has received B-cell maturation antigen (BCMA)-targeted therapy.
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
- Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
- Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
- Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
- Urine M-protein \>= 200 mg/24 hours.
- In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
- Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb). \-- US and Puerto Rico only: Participant must...
- Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
- Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
- Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would...
- Central nervous system involvement of MM.
- Has received B-cell maturation antigen (BCMA)-targeted therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Berkeley, California, United States
- Fullerton, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Lone Tree, Colorado, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Elmhurst, Illinois, United States
- Springfield, Illinois, United States
- Baton Rouge, Louisiana, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Lansing, Michigan, United States
- Rochester, Minnesota, United States
- Columbia, Missouri, United States
+ 132 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 Birmingham, Alabama, United States; Phoenix, Arizona, United States; Berkeley, California, United States; Fullerton, California, United States; Loma Linda, California, United States; Los Angeles, California, United States and 146 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.