IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDickran Kazandjian, MD
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) criteria documented initially prior to induction treatment.
Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38).
Documentation of attaining a best response of partial response (PR) or better but MRD+ (sensitivity: ≤10^-5) after at least 4 cycles of combination therapy.
Age ≥18 years.
Disqualifiers
Patients who have received prior systemic therapies for MM other than initial IMiD/PI/anti-CD38-based combination therapy (receiving limited cycles of other induction therapies, eg, cyclophosphamide, bortezomib and dexamethasone (CyBorD) or pulse dexamethasone prior to main induction is allowed). Exclusions include high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and allogeneic stem cell transplant (SCT).
Patients who are receiving any other investigational agents for any reasons.
Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy (Sections 4.8, 4.9, and 7).
Trial design
Treatments tested in this trial
- Linvoseltamab
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Dickran Kazandjian, MD
Lead sponsor
University of Miami
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov