IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

NCT06376526 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20230236
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Minimal Residual Disease (MRD) Negativity Rate

  The rate of MRD-negativity among participants. Defined by rate of MRD negativity using clonoSEQ MRD® assay at sensitivities of 10\^-5 and 10\^-6. MRD negativity is defined as 0 residual clonal cells in a bone marrow biopsy sample

  Up to 6 months

Secondary Outcomes (4)

• Sustained MRD-Negativity Rate

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 2 years

• Overall Survival

  Up to 2 years

• Number of Participants Experiencing Treatment-Related Adverse Events

  Up to 7 months

Study Arms (1)

Linvoseltamab Group

EXPERIMENTAL

Participants in this group will be administered a fixed duration of Linvoseltamab for four to six 28-day cycles, depending on minimal residual disease (MRD) conversion status. After four cycles, participants that are MRD-negative will no longer receive study treatment. Participants that are MRD-positive will receive an additional two cycles of Linvoseltamab. Total participation duration is up to 3 years.

Biological: Linvoseltamab

Interventions

Linvoseltamab BIOLOGICAL

Participants will be administered Linvoseltamab intravenously (IV), using a step-up dosing schedule as follows: * Cycle 1, Day 1: 5mg * Cycle 1, Day 8: 25mg * Cycle 1, Days 15 and 22: 200mg * Cycles 2 and 3, Days 1, 8, 15 and 22: 200mg * Cycle 4, Days 1 and 15: 200mg. For participants who are MRD-positive after four (4) cycles of study treatment: * Cycles 5 and 6, Days 1 and 15: 200 mg

Linvoseltamab Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 very good partial response (VGPR) or better but MRD+ (sensitivity: ≤10\^-5) after at least 4 cycles of combination therapy.
• Note: Patients who at baseline prior to initial combination therapy did not have IMWG evaluable disease and therefore a response assessment of VGPR was unable to be made but currently have residual MM by M-protein and/or involved light chains and/or MRD positivity may enroll. Also, patients who have no apparent bone marrow (BM) residual disease but rather extramedullary disease as evidenced by positron emission tomography (PET)/computed tomography (CT) may enroll.
• Age ≥18 years.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg, pain) may be allowed after discussion with the PI (APPENDIX A).
• Adequate organ function, which is defined as follows:
• a. Absolute neutrophil count (ANC) ≥1,000 cells/microliter (mcL) (unless patient has ethnic/cyclic neutropenia or if neutropenia is thought to be due to MM)
• b. Platelets ≥50,000 platelets/mcL
• c. Hemoglobin ≥8 g/dL (transfusions permitted)
• d. Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of \<3 X ULN)
• e. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) ≤ 2.5 X ULN
• f. Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 (note that measured glomerular filtration rate \[GFR\], ie, 24-hour urine, can also be used) based on institutional standard
• g. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 6 months following the last dose of study treatment. For more information on contraception requirements, please refer to Section 4.11.
• h. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. For more information on the informed consent process, please refer to Section 15.1.

You may not qualify if:

• Note: Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug is not permitted.
• 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).
• Patient has any of the following:
• Human immunodeficiency virus (HIV)-positive with 1 or more of the following:
• i. History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation 4 (CD4) count \<350 cells/mm3
• ii. Detectable viral load during screening or within 6 months prior to screening
• iii. Not receiving highly active anti-retroviral therapy
• iv. Had a change in anti-retroviral therapy within 6 months of the start of screening
• v. Receiving anti-retroviral therapy that may interfere with study treatment as assessed after discussion with the Sponsor-Investigator in consultation with study pharmacist
• Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)-deoxyribonucleic acid \[DNA\] positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and/or antibodies to hepatitis B surface antigen (anti-HBs)) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
• Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-ribonucleic acid (RNA) testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study.
• Female patient refuses to discontinue breastfeeding her infant during study treatment or within 6 months after receiving the last dose of study treatment (Section 4.11).

Sponsors & Collaborators

• Dickran Kazandjian, MD: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dickran Kazandjian, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dickran Kazandjian, MD

CONTACT

305-243-5001; dkazandjian@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)