Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06465316

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

26

Participants Needed

14

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving iberdomide in combination with teclistamab may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma.

CONDITIONS

Official Title

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of multiple myeloma according to international criteria
  • If previously had autologous stem cell transplant, it must have been more than 100 days ago
  • Disease has progressed after at least 4 prior anti-myeloma treatments including one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody
  • Measurable disease by specific protein levels in blood or urine; non-secretory disease patients allowed
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky score 60 or higher)
  • Hemoglobin, neutrophil count, platelets, liver enzymes, kidney function, and urine protein levels within defined limits
  • HIV patients on effective therapy with undetectable viral load within 6 months are eligible
  • Patients with controlled hepatitis B or cured hepatitis C are eligible
  • Patients with treated or stable brain metastases may participate
  • Prior or concurrent cancers allowed if not interfering with study
  • Cardiac function assessed as New York Heart Association class II or better
  • Females of childbearing potential must use effective contraception and have negative pregnancy tests before and during treatment
  • Men must agree to contraception and abstain from donating sperm during and after treatment
  • Agree to not donate blood during and after treatment
  • Ability to understand and sign informed consent
  • Willingness to comply with study visits and provide required samples
  • Willingness to return for follow-up visits
Not Eligible

You will not qualify if you...

  • Active plasma cell leukemia, AL amyloidosis, POEMS syndrome, or Waldenstrom macroglobulinemia
  • Prior treatment with anti-BCMA bispecific antibodies or cereblon E3 ligase modulators including iberdomide
  • Received plasmapheresis within 7 days before study
  • Prior allogeneic stem cell transplant (autologous allowed)
  • Received live vaccines within 30 days before study (COVID-19 vaccine allowed anytime)
  • Active infections requiring treatment
  • Unresolved side effects from prior treatment greater than grade 2, except alopecia or mild neuropathy
  • Major surgery within 4 weeks before study
  • Uncontrolled illness or conditions making study participation unsafe
  • Active mucosal or internal bleeding
  • Unstable liver or biliary disease, except stable chronic liver disease
  • Known allergies to teclistamab, iberdomide, or study components
  • Currently on anticancer therapies other than allowed hormonal or limited radiotherapy
  • Need for high-dose immunosuppressive medications
  • Use of strong CYP3A4/5 inhibitors or inducers
  • Receiving other investigational treatments
  • Pregnant or breastfeeding women
  • Unable or unwilling to use blood clot prevention measures required by the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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