Actively Recruiting
A Phase 1b Trial of Teclistamab Combined With Iberdomide for Relapsed or Refractory Multiple Myeloma
Led by National Cancer Institute (NCI) · Updated on 2026-05-27
26
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of iberdomide combined with teclistamab in patients with multiple myeloma that has returned after improvement or does not respond to treatment. Iberdomide targets proteins that help myeloma cells survive, while teclistamab is an immunotherapy that may help the immune system attack cancer and slow its growth. This phase Ib trial aims to find the recommended dose and observe antitumor activity and immune changes related to treatment. Participants receive teclistamab injections under the skin on specific days during the first cycle and then weekly in later cycles. Iberdomide is taken orally daily on days 1 to 21 starting from the second cycle. Each cycle lasts 28 days and can continue for up to 4 years unless the disease progresses or side effects become unacceptable. Throughout the trial, patients also undergo blood and urine tests, bone marrow biopsies, and imaging scans such as PET/CT or PET/MR. During the study, participants will have regular assessments including laboratory tests, bone marrow examinations, and imaging to monitor their response and safety. After finishing study treatment, they will have follow-up visits every 3 to 6 months for up to 2 years. Researchers will measure outcomes like the best dose of iberdomide, treatment side effects, tumor response, survival, and immune system changes.
CONDITIONS
Brief Title
Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed multiple myeloma according to International Myeloma Working Group criteria
- At least 100 days since autologous stem cell transplant if previously done
- Disease progression after 4 or more prior anti-myeloma treatments including one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody
- Measurable disease by specified blood or urine markers or non-secretory disease
- Age 18 years or older
- ECOG performance status of 2 or less (Karnofsky score 60 or higher)
- Hemoglobin, neutrophil count, platelets, liver and kidney function within specified ranges
- Controlled HIV, hepatitis B or C infection per protocol
- Treated or stable brain metastases allowed under conditions
- Cardiac function class II or better
- Females of child-bearing potential must use effective contraception and have negative pregnancy tests
- Willingness to sign informed consent and comply with study visits and procedures
- Willingness to return for follow-up visits
You will not qualify if you...
- Active plasma cell leukemia, primary amyloidosis, POEMS syndrome, or Waldenstrom macroglobulinemia
- Prior treatment with anti-BCMA bispecific antibodies or cereblon E3 ligase modulators
- Recent plasmapheresis within 7 days
- Prior allogeneic stem cell transplant (autologous allowed)
- Recent live vaccine within 30 days
- Active infection requiring treatment
- Unresolved toxicities grade 3 or higher except for certain conditions
- Major surgery within 4 weeks
- Uncontrolled illness or conditions making participation hazardous
- Active bleeding or unstable liver/biliary disease
- Allergies to study drugs or components
- Use of other anticancer therapies except specific exceptions
- Need for high dose immunosuppressive medications
- Use of strong CYP3A4/5 inhibitors or inducers
- Participation in other investigational drug studies
- Pregnant or breastfeeding women
- Unable or unwilling to follow thromboembolism prevention requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants receive teclistamab injections on multiple days during each 28-day cycle and take iberdomide orally daily on days 1-21 from cycle 2 onward. This treatment continues for up to 4 years unless the disease progresses or unacceptable side effects occur. Participants also undergo blood and urine sample collection, bone marrow aspiration and biopsy, and PET/CT or PET/MR scans throughout the trial.
Multiple visits per 28-day cycle based on dosing schedule
Duration - Up to 2 years
After completing treatment, participants have follow-up visits every 3 to 6 months for up to 2 years to monitor their health and disease status.
Visits every 3 to 6 months
Trial Site Locations
Total: 14 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
3
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
6
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Suspended
8
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
9
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
10
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
11
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
14
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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