The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma.
People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma.
This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Inclusion Criteria:
Exclusion Criteria:
Phase 2
Enrollment: 52 patients (estimated)
View MoreApril 27, 2026
As of April 27, 2026, 59 treated patients were included, including 45 treated with Tec (including 6 SRI patients) and 14 with Rd. Median age was 65 years, 23 patients (39%) were female, 24 (41%) had high-risk cytogenetics and 38 (64%) were high-risk per 20-2-20 criteria. Baseline characteristics were balanced between arms. No DLTs were observed in the Tec SRI.
Across the treated population, Tec induced deeper responses than Rd, including CR/sCR in 73% versus 0% of patients, respectively, and ≥VGPR in 87% versus 14% (both p<0.001). Among MRD-evaluable patients, Tec induced MRD negativity at 10-5 in 36/44 patients (81%), including 34/36 patients (94%) with ≥VGPR; no Rd-treated patient achieved MRD negativity. MRD negativity was sustained in all patients.
At a median follow-up of 23.4 months, 3 progression events of SLiM-CRAB and/or biochemical PD occurred in the Tec arm and 5 in the Rd arm. While median PFS was not reached in either arm, Tec significantly improved PFS compared with Rd (p=0.007), with Kaplan–Meier–estimated 2-year PFS rates of 92% and 51%, respectively (Fig 1).
CRS occurred in 32/45 Tec-treated patients (71.1%); all were grade 1/2. No ICANS or deaths occurred. Grade ≥3 AEs included neutropenia (Tec 16/45, 36% [gr4, n=8]; Rd 11/14, 79% [gr4, n=4]), thrombocytopenia (Tec 2/45, 4% [gr4, n=1]; Rd 2/14, 14%), infections (Tec 9/45, 20%; Rd 3/14, 21.4%) and ALT/AST elevation (Tec 5/45, 11%; Rd 1/14, 7%). Grade ≥3 lymphopenia occurred only in the Tec arm (4/45, 9% [gr4, n=1]) as well as one gastrointestinal AE (2.2%). All Tec-treated patients received IVIG.
December 09, 2023
At the time of data cut off, 19 patients have been enrolled to study with median follow up of 6 months. The median age is 59 years old (range 35-73) with 9 females (47%) and 10 males ( 53%). Sixty-four percent of patients that had evaluable FISH results had high-risk abnormalities as follows: 1q gain (7 pts), t(4;14) 1 patient.
No DLTs were observed in the safety run-in cohort and patients are now enrolling into the randomized portion of trial. In the TEC-cohort (12 patients), grade 3 or greater hematologic toxicities were neutropenia (4 patients, resolved) and thrombocytopenia (1 patient, resolved). Grade 3 or greater non-hematologic toxicities were ALT increased in 3 patients (grade 3, resolved) and pancreatitis in 1 patient (grade 3, resolved). Infections occurred in 9 patients but only 1 patient had grade 3 infection (sinusitis). Remainder of the infections were low grade and were mostly upper respiratory infections (6 patients). One patient had grade 2 uveitis. CRS occurred in 75% of patients (all grade 1 except 2 patients with grade 2 CRS requiring tocilizumab, all resolved). No patients experienced ICANS with no delayed neurotoxicity observed. All patients treated with TEC are receiving IVIG with mean IgG level at start of IVIG treatment of 418 mg/dL, with 64% of patients achieving normalization of IgG values within two IVIG doses.
In the TEC- treated cohorts (12 patients), the ORR is 100% with 42% achieving a CR, 25% VGPR, 33% PR. Four patients with high risk FISH receiving TEC have achieved a CR within 5 cycles. In control arm of lenalidomide and dexamethasone (3 patients), the ORR is 66% without any complete responses to date. Of the 8 evaluable patients treated with TEC, the MRD negative rate at 10-6 is 100%, including 2 patients with VGPR-MRD negative disease. Average time to MRD negativity observed among evaluable patients was 4.25 cycles. No patients have progressed on treatment. Stem cell collection was successful in all eligible patients with an average stem cell yield of 9.06 x 106CD34+ cells/kg.
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Denver, CO
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