Actively Recruiting
ERd Combination Treatment in Newly Diagnosed Multiple Myeloma
Led by University of Miami · Updated on 2025-10-07
104
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.
CONDITIONS
Official Title
ERd Combination Treatment in Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with histologically confirmed Multiple Myeloma based on IMWG criteria and measurable disease within the past 4 weeks (or 8 weeks if prior therapy received)
- Evidence of underlying organ damage or myeloma defining event related to plasma cell disorder
- Measurable disease defined by serum or urine monoclonal protein or abnormal serum free light chain levels
- Adult male or female aged 18 years or older
- ECOG performance status 0-2
- Adequate organ and marrow function as defined by specific blood count and liver/kidney function thresholds
- Willingness to enroll in the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program
- Female participants of childbearing potential must have negative pregnancy tests and agree to pregnancy testing during study
- Female participants must use effective contraception or not be of childbearing potential
- Female participants must agree not to donate eggs or breastfeed during and after treatment
- Male participants must agree to use condoms during and after treatment and not donate sperm
- Ability to understand and sign informed consent
- Willingness and ability to follow study lifestyle restrictions
You will not qualify if you...
- More than one cycle of prior or concurrent systemic treatment for Multiple Myeloma, with some permitted exceptions
- Known active central nervous system involvement or myelomatous meningeal signs
- Major surgery within 14 days before enrollment
- Peripheral neuropathy of grade 3 or higher
- Receiving other anti-myeloma investigational agents
- Live attenuated vaccine within 4 weeks of study treatment
- Contraindications to concomitant medications used in the study
- HIV positive with uncontrolled disease or therapy issues
- Active hepatitis B or C infection without viral clearance
- Chronic obstructive pulmonary disease with FEV1 below 50% predicted
- Moderate or severe persistent or uncontrolled asthma
- Positive SARS-CoV-2 test or suspected infection within 5 days prior to enrollment
- History of allergic reactions to similar study agents
- Female patients unwilling to discontinue breastfeeding during and after treatment
- Male participants planning to father a child during or shortly after treatment
- Certain unstable or severe cardiac conditions
- Uncontrolled illnesses or infections that could affect study participation
- Active malignancies other than smoldering Multiple Myeloma requiring recent treatment
- Impaired decision-making capacity preventing study compliance or consent
- Active, uncontrolled infections or recent systemic anti-infective therapy within specified timeframes
- Other conditions that might compromise patient safety or study integrity as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
C
Carl O Landgren, MD
CONTACT
D
Dickran Kazandjian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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