Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

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.

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

Dickran Kazandjian, MD

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.

IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

Immuno-consolidation for Newly Diagnosed Multiple Myeloma Using Lack of MRD Negativity After Initial cOmbination Therapy to Pursue Deeper Responses With Linvoseltamab ANd Delay Transplant

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

The sustained rate of MRD-negativity among participants will be reported. The duration of time in months measured from the first time the participant achieves an MRD-negative bone marrow (BM) biopsy result until the time the participant has relapsed from MRD-negativity objectively documented with an MRD-positive BM result.

Progression-free survival among study participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until disease progression or death.

Overall survival (OS) among study participants will be assessed during treatment and clinical follow-up. OS is defined from start of treatment until death from any cause.

The number of participants experiencing treatment-related adverse events will be reported. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Spots Global Cancer Trial Database for IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

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