Actively Recruiting
IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
Led by Dickran Kazandjian, MD · Updated on 2025-08-14
28
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
D
Dickran Kazandjian, MD
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.
CONDITIONS
Official Title
IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of newly-diagnosed multiple myeloma according to International Myeloma Working Group criteria before induction treatment
- Received initial combination therapy with at least two of the following: immunomodulatory drug, proteosome inhibitor, or anti-CD38
- Achieved very good partial response or better but remain MRD-positive after at least 4 cycles of combination therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group Performance Status of 0 or 1 (ECOG ≤ 1); ECOG 2 allowed if due to local myeloma symptoms after discussion with investigator
- Adequate organ function as defined by specific blood counts, liver and kidney function thresholds
- Negative pregnancy test for women of childbearing potential at screening
- Willing and able to provide written informed consent
- Willing and able to comply with clinic visits and study-related procedures
You will not qualify if you...
- Prior systemic therapies for multiple myeloma beyond initial combination therapy (except limited induction therapies like CyBorD or pulse dexamethasone); high-dose melphalan or stem cell transplants excluded
- Receiving other investigational agents
- Received live attenuated vaccine within 4 weeks before study treatment
- Contraindications to medications used in study or pre-treatment prophylaxis
- HIV-positive with specific conditions such as low CD4 count, detectable viral load, or untreated
- Active hepatitis B or C infection as defined by tests and treatment status
- Allergic reactions to similar compounds as study drugs
- Breastfeeding and unwilling to discontinue during study and 6 months after last dose
- Unwillingness to use effective contraception as required
- Certain cardiac conditions including advanced heart failure, recent heart attack, significant arrhythmias, or unstable angina
- Uncontrolled illnesses including infections, thromboembolism, fibrosis, autoimmune diseases (with some exceptions), or psychiatric/social issues limiting compliance
- Active malignancy other than multiple myeloma requiring recent treatment
- Any condition that compromises patient safety or protocol compliance as judged by investigator
- Impaired decision-making capacity preventing study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
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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