Actively Recruiting
A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-09
18
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).
CONDITIONS
Official Title
A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory multiple myeloma treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody, having received at least 2 prior lines of therapy
- Measurable disease by serum myeloma protein ≥0.5 g/dL, urine M-protein ≥200 mg/24 h, involved light chain >10 mg/dL with abnormal ratio, new or enlarged plasmacytoma by imaging or biopsy, or >30% clonal plasma cells in bone marrow biopsy
- Prior BCMA-directed therapy allowed if >90 days ago and BCMA presence confirmed; prior BCMA bispecific antibodies not allowed
- Prior bispecific antibodies with non-BCMA targets allowed if >60 days prior
- Allogeneic stem cell transplant allowed if >6 months prior
- Age 18 years or older
- ECOG Performance Status 0-1; PS-2 allowed if due to bone pain only
- Adequate organ function including hemoglobin ≥8 g/dL, ANC ≥1.0 × 10⁹/L, platelets ≥75 × 10⁹/L or ≥50 × 10⁹/L based on plasma cell infiltration, bilirubin ≤2 × ULN (with exceptions), AST and ALT ≤2.5 × ULN, eGFR ≥30 mL/min, and corrected serum calcium ≤14 mg/dL
- Resolved acute effects of prior therapy to baseline or grade ≤1 except peripheral neuropathy from bortezomib
- Female participants must not be pregnant or breastfeeding and meet contraception requirements or be non-childbearing potential
- Male participants must agree to abstain or use condoms with partners of childbearing potential during treatment and for 28 days after
- Signed informed consent
- Willingness and ability to comply with study procedures
You will not qualify if you...
- Prior treatment with BCMA-targeted bispecific antibody
- Prior treatment with mezigdomide
- Systemic anti-myeloma therapy or plasmapheresis within 14 or 7 days before first study dose
- Use of investigational drug within 21 days or five half-lives before first dose
- Radiation therapy within 14 days before study entry (except limited bone radiation)
- Live or investigational vaccines within 4 weeks before first dose (non-live vaccines allowed)
- Autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior
- CAR T therapy within 90 days prior
- Primary AL amyloidosis
- Major surgery within 4 weeks before starting treatment
- Active internal bleeding
- Active renal conditions (except isolated proteinuria from myeloma)
- Active liver or biliary disease except certain stable conditions
- Active or prior malignancy other than multiple myeloma unless disease-free or stable for 2 years, with some exceptions
- Significant cardiovascular risks including untreated arrhythmias, recent heart attack or stroke, and severe heart failure
- Known allergy to teclistamab, mezigdomide, or study components
- Pregnant or breastfeeding individuals
- Active infection requiring treatment
- HIV infection unless stable on therapy with specific criteria
- Positive hepatitis B surface antigen or core antibody without confirmatory negative DNA test
- Active hepatitis C infection
- Serious unstable medical or psychiatric conditions affecting safety or compliance
- Use of strong CYP3A modulators or proton-pump inhibitors within 2 weeks before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
M
Malin Hultcrantz, MD, PhD
CONTACT
R
Ross Firestone, MD, PhD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here