Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Smoldering Multiple Myeloma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Precancerous Conditions

Hypergammaglobulinemia

Central Nervous System Stimulants

All Drugs and Chemicals

Antineoplastic Agents

Other Dietary Supplements

Caffeine

Daratumumab

Participants will receive the recommended dosage combination treatment Tec-Dara.

Dosing and treatment schedule for participants in this group will be determined after Cohort A is completed.

Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.

Teclistamab

Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.

Talquetamab

Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.

Daratumumab SC

Michelle Armogan

Carl O Landgren, MD, PhD

The purpose of this study is to see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.

Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)

Teclistamab or Talquetamab in Combination With Daratumumab SC for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Sequential Cohort Immuno-Oncology Study to REVIVE Early Myeloma

MRD negative (10\^-5 sensitivity by flow cytometry) as best response by completion of 12 cycles. MRD negative result means no disease is detected after treatment. Status of MRD will be assessed using International Myeloma Working Group (IMWG) Consensus Criteria for Response and Minimal Residual Disease Assessment in Multiple Myeloma, per discretion of treating physician.

The number of treatment related serious adverse events (SAEs) and grade 3 or higher adverse events (AEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

Overall response rate (ORR) is determined by the number of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to protocol therapy. Response will be assessed using standard International Myeloma Working Group (IMWG) Criteria for Response in Multiple Myeloma, per physician discretion.

The duration of response (DoR) is measured as the time from when participants meet the criteria for stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to protocol therapy using International Myeloma Working Group (IMWG) Criteria until the time progressive disease (PD) is documented, per discretion of treating physician.

The rate of best objective responses (BoR) is determined by the number of participants who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response to protocol therapy using International Myeloma Working Group (IMWG) Criteria, per discretion of treating physician.

The rate of minimal residual disease (MRD) negativity by next-generation sequencing (NGS) after 24 cycles of the protocol therapy is determined by the number of participants who achieve MRD negativity by 10\^-6 sensitivity NGS, per discretion of treating physician.

Sustained MRD negativity is determined by the number of participants who achieve MRD negativity 1, 2, and, 4 years apart, without any positive MRD in between, per discretion of treating physician.

The duration of MRD negativity is measured as the time from the first time participants achieve MRD negativity until the participant has relapsed from MRD negativity, per discretion of treating physician.

Clinical progression-free survival (clinPFS) is measured as the time from the participants start of protocol therapy to the clinical development of symptomatic multiple myeloma or death, per discretion of treating physician.

Biochemical progression-free survival (bioPFS) is measured as the time from the participants start of protocol therapy to progression of multiple myeloma in the blood or death occurs, using International Myeloma Working Group (IMWG) Criteria, per discretion of treating physician.

Overall Survival (OS) is determined by the amount of time from participants start of protocol therapy to death or to last known timepoint the participant was alive.

Serum samples will be analyzed to determine concentrations of Teclistamab and Talquetamab using validated, specific, and sensitive methods.

Serum from venous blood samples will be collected for measurement of serum concentrations of Teclistamab (Cohort A - Teclistamab only) and the generation of Anti-drug Antibodies (ADAs) where applicable to Teclistamab per the Study Schedule.

Spots Global Cancer Trial Database for Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)

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