Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

NCT05972135 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MM165
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 17

Brief Summary

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Conditions

Multiple Myeloma

Keywords

Teclistamab (TECVAYLI™); Humanized IgG-4 PAA bispecific antibody; CD3 receptor complex; RRMM-Relapsed or Refractory Multiple Myeloma; MM-Multiple Myeloma; Tocilizumab prophylaxis; CRS- Cytokine Release Syndrome; Neurologic toxicity; ICANS-Immune Effector Cell-associated Neurotoxicity Syndrome; Talquetamab (TALVEY™); GPRC5D; BCMA; Oral dexamethasone prophylaxis

Outcome Measures

Primary Outcomes (1)

• Incidence of CRS of any grade during the first two cycles

  Evaluate the overall incidence of CRS in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.

  From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)

Secondary Outcomes (29)

• Incidence of recurrent CRS of any grade

  From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)

• Incidence of CRS of any grade

  Up to 12 months of teclistamab or 6 months for talquetamab treatment

• Incidence of recurrent CRS of any grade

  Up to 12 months of teclistamab or 6 months for talquetamab treatment

• Incidence of Grade ≥2 CRS

  From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)

• Incidence of Recurrent Grade ≥2 CRS

  From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)

Study Arms (3)

Teclistamab/Tocilizumab

EXPERIMENTAL

Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy.

Drug: Teclistamab; Drug: Tocilizumab

Talquetamab/Tocilizumab

EXPERIMENTAL

Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm.

Drug: Talquetamab; Drug: Tocilizumab

Teclistamab/Oral Dexamethasone

EXPERIMENTAL

Participants will receive step-up dosing of Teclistamab followed by weekly dosing for two cycles, every other week during Cycles 3-6 and once every 4 weeks from Cycles 7 through 12 until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better starting with Cycle 3.

Drug: Teclistamab; Drug: Oral Dexamethasone

Interventions

Oral Dexamethasone DRUG

Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.

Also known as: Decadron

Teclistamab/Oral Dexamethasone

Teclistamab DRUG

Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.

Also known as: (TECVAYLI™)

Teclistamab/Oral Dexamethasone; Teclistamab/Tocilizumab

Talquetamab DRUG

Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks

Also known as: TALVEY™

Talquetamab/Tocilizumab

Tocilizumab DRUG

Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.

Also known as: Actemra

Talquetamab/Tocilizumab; Teclistamab/Tocilizumab

Eligibility Criteria

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

You may qualify if:

• Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent
• Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).
• Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.
• Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody.
• Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1.
• Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.
• Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
• Serum M-protein level ≥0.5 g/dL; or
• Urine M-protein level ≥200 mg/24 hours; or
• Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
• For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).
• Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
• No detectable viral load (i.e., \<50 copies/mL) at screening
• CD4+ count \>300 cells/mm3 at screening
• No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening

You may not qualify if:

• Has a rapidly progressing disease per investigator assessment.
• Has plasma cell leukemia (\>2.0×10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
• Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM.
• Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase.
• Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:
• Any malignancy that was not progressing nor requiring treatment change in the last 12 months.
• Malignancies treated within the last 12 months and considered at very low risk for recurrence:
• Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \<3 cm, no CIS).
• Skin cancer (non-melanoma or melanoma).
• Noninvasive cervical cancer.
• Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
• Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).
• Other malignancy that is considered at minimal risk of recurrence.
• Has Grade ≥3 hematologic AEs or Grade ≥3, clinically significant non-hematologic AEs.
• Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Johnson & Johnson: collaborator

Study Sites (17)

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

RECRUITING

Medical Oncology Hematology Consultants

Newark, Delaware, 19713, United States

RECRUITING

Florida Cancer Specialists

Lake Mary, Florida, 32746, United States

WITHDRAWN

Maryland Oncology Hematology

Columbia, Maryland, 21044, United States

RECRUITING

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

RECRUITING

Virginia Oncology Associates

Elizabeth City, North Carolina, 27909, United States

RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

RECRUITING

Oncology Associates of Oregon

Eugene, Oregon, 97401, United States

RECRUITING

TriStar Bone Marrow Transplant

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt- Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Oncology

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Blue Ridge Cancer Center

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Cytokine Release Syndrome

Interventions

talquetamab; tocilizumab; Dexamethasone; Calcium Dobesilate

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; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Peter A. Forsberg, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Central Study Contacts

Sarah Cannon Development Innovations, LLC

CONTACT

1-844-710-6157; SCRI.InnovationsMedical@scri.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 2, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)