Study on ERd Combination Treatment for Newly Diagnosed Multiple Myeloma
Sponsor: University of Miami
Sponsor score: 40
ClinicalTrials ID:NCT06997081
This clinical trial is exploring the effects of a new treatment combination using Elranatamab, Lenalidomide, and Dexamethasone for patients who have been newly diagnosed with Multiple Myeloma.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out how well a combination of three drugs—Elranatamab, Lenalidomide, and Dexamethasone—works in treating people who have recently been diagnosed with Multiple Myeloma, a type of blood cancer.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older who have been newly diagnosed with Multiple Myeloma.
- Must have measurable disease based on specific medical tests within the last 4 to 8 weeks.
- Evidence of organ damage or specific myeloma-related events, such as high calcium levels, anemia, bone damage, or abnormal plasma cells in the bone marrow.
- Must have good overall health with a performance status score of 0 to 2.
- Adequate organ and bone marrow function as shown by specific blood tests.
- Willing to participate in a safety program for Lenalidomide.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Men must agree to use condoms during the study and for a period after the last dose of treatment.
- Must be able to understand and sign a consent form.
- Must be willing to follow study guidelines and lifestyle restrictions.
Exclusion Criteria
- Have received more than one cycle of prior treatment for Multiple Myeloma.
- Have active central nervous system involvement or signs of myeloma in the brain or spinal cord.
- Have had major surgery within 14 days before joining the study.
- Have a history of severe nerve damage.
- Are currently receiving other investigational treatments for Multiple Myeloma.
- Have received a live vaccine within 4 weeks before starting the study treatment.
- Have certain infections like active hepatitis B or C, or HIV with specific conditions.
- Have severe lung diseases or uncontrolled asthma.
- Have a history of severe allergic reactions to similar drugs.
- Women who are pregnant or breastfeeding.
- Men planning to father a child during or shortly after the study.
- Have certain heart conditions or uncontrolled illnesses that could interfere with the study.
- Have had another active cancer within the last 3 years, except for certain skin cancers or very early-stage cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33136 | Miami | Florida |
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