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:
Documented multiple myeloma satisfying the International Myeloma Working Group (IMWG) diagnostic criteria36 (evidence of myeloma defining event attributed to underlying plasma cell disorder) with measurable disease defined as:
Measurable disease within the past 4 weeks defined by any of the following:
Standard risk multiple myeloma - excluding patients with high risk cytogenetic abnormality (HRCA) according to the IMS/IMWG 2024 Consensus Definition:
Newly diagnosed patient considered a candidate for high-dose chemotherapy and autologous stem cell transplant
a. For patients who received one complete cycle of Dara-RVd at MSK, patients can enter treatment at cycle 2 at the discretion of treating investigator and PI
Have adequate organ and hematologic function:
Exclusion Criteria:
Significant, uncontrolled comorbid conditions that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in the study. Examples include, but are not limited to
i. Subjects with resolved infection (i.e., subjects who are HBsAg negative with antibodies to total hepatitis B core antigen [anti-HBc] with or without the presence of hepatitis B surface antibody [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
ii. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of HBV vaccination, do not need to be testing for HBV DNA by PCR.
h. Seropositive for hepatitis C i. Except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy.
i. Clinically significant cardiac disease, including: i. Myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV) ii. Uncontrolled cardiac arrhythmia
Phase 1/2
Enrollment: 65 patients (estimated)
View MoreSeptember 24, 2026
Patients with standard-risk disease, as defined by 2025 International Myeloma Workshop–International Myeloma Working Group (IMW-IMWG) consensus genomic staging criteria, receive three cycles of Dara-RVd, followed by stem cell collection, and then receive three cycles of Tec-RVd before autologous transplant. Teclistamab is stepped up in cycle 4 (0.06, 0.3, and 1.5 mg/kg) and given at 3.0 mg/kg subcutaneously on day 1 of cycles 5 and 6. Bortezomib 1.3 mg/m² is given on days 1, 8, and 15. Lenalidomide 25 mg is given on days 8 to 21 in cycle 4 and given on day 1 to day 21 of cycles 5 and 6. Maintenance consists of 2 years of daratumumab 1,800 mg every 4 weeks plus teclistamab 3.0 mg/kg every 8 weeks. Prophylactic tocilizumab was allowed.
Since September 2025, six patients have been enrolled in phase 1. Median age was 63 years (range, 43-73 years), five were men, and five had stage II disease according to the Revised International Staging System (R-ISS). At a median follow-up of 224 days, grade 3/4 treatment-related lymphopenia had occurred in all six patients, neutropenia occurred in four (67%), and thrombocytopenia occurred in one (17%). One patient had two episodes of febrile neutropenia, both noted before administration of Tec-RVd began.
Cytokine release syndrome reached grade 2 in two patients and resolved with tocilizumab. No grade 3/4 CRS, no ICANS of any grade, and no grade 3/4 infections were reported; half the patients received IV immunoglobulin.
At the end of cycle 6, all five response-evaluable patients had responded. All four MRD-evaluable patients were negative at both 10⁻⁵ and 10⁻⁶. A fifth was MRD unevaluable, and one patient was still finishing induction.
Stem cell collection was completed for all six patients, with a median CD34+ yield of 5.7 × 10⁶ (range, 3.7-11.3). All six continue to follow the protocol with autologous stem cell transplant planned.
Phase 2 opened March 25, 2026; seven more patients have been enrolled so far. MRD negativity at 10⁻⁵ after six induction cycles is the primary end point of phase 2. Secondary end points include sustained MRD negativity, progression-free survival, event-free survival, overall survival, and health-related quality of life. Updated results are expected at the meeting.
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