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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara)
with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd)
or daratumumab SC in combination with bortezomib and dexamethasone (DVd) in Part 1 and to
evaluate the pharmacokinetics (PK), safety, and efficacy of the Tec-Dara regimen when
teclistamab is administered using a alternative dosing schedule in Part 2.
Multiple Myeloma
Phase III
Adults
Mol. targeted/Immunotherapy/Biologics
Bortezomib (BTZ), Daratumumab, Dexamethasone, Pomalidomide (POM)(CC-4047), Teclistamab
Sengsayadeth, Salyka
International
Vanderbilt University
07-13-2022
Treatment
VICCPCL2194
NCT05083169

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio

Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion

Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen

Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment

Have clinical laboratory values within the specified range



Exclusion Criteria:

Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:

A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,

A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization

Received any prior B cell maturation antigen (BCMA)-directed therapy

Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG

Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization

Received a live, attenuated vaccine within 4 weeks before randomization

Plasma cell leukemia at the time of screening, Waldenstrm's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

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