Actively Recruiting
Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
Led by University of Alabama at Birmingham · Updated on 2026-05-13
300
Participants Needed
10
Research Sites
311 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
J
Janssen Scientific Affairs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.
CONDITIONS
Official Title
Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years with no upper age limit
- Newly diagnosed multiple myeloma requiring therapy
- ECOG performance status between 0 and 2
- No prior multiple myeloma therapy except limited dexamethasone, bortezomib, cyclophosphamide, or lenalidomide within 4 weeks
- Measurable disease by specified serum or urine monoclonal protein or free light chain criteria
- Adequate laboratory values for hemoglobin, platelets, neutrophils, liver enzymes, kidney function, bilirubin, and calcium
- Negative pregnancy test for women of childbearing potential before and during the study
- Women must use effective contraception or practice abstinence; men must use condoms and agree to contraception measures
- Willingness to follow lifestyle restrictions and sign informed consent
- Enrollment in Revlimid REMS program
- Eligibility for autologous hematopoietic cell transplant as assessed by investigator
- At least 25% of enrolled participants will be from ethnic minorities
You will not qualify if you...
- Diagnosis of plasma cell leukemia, primary light chain amyloidosis, POEMS syndrome, or Waldenstrom's macroglobulinemia
- Allergies or intolerance to study drugs or their ingredients
- Previous exposure to teclistamab, anti-BCMA therapy, daratumumab, anti-CD38 therapy, or recent investigational treatments or vaccines
- Active or suspected central nervous system involvement of multiple myeloma
- Other active malignancies except certain treated and cured cancers
- Stroke or seizure within 6 months
- Severe lung diseases including COPD with low lung function or moderate to severe asthma
- Prior allogeneic stem cell or solid organ transplant
- Pregnancy or plans to father a child during study and 90 days after
- Significant heart conditions such as advanced heart failure or recent heart attack
- HIV, active hepatitis B or C infections
- Recent major surgery or insufficient recovery
- Significant neuropathy within 21 days prior to registration
- Contraindications to supportive medications
- Medical or psychiatric conditions that may interfere with study or pose risk
- History of non-compliance with medical treatments
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Columbia University
New York, New York, United States, 10032
Actively Recruiting
4
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
5
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
7
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
8
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
9
University of Wisconsin - Carbone
Madison, Wisconsin, United States, 53792
Actively Recruiting
10
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
L
Luciano Costa, MD
CONTACT
M
Margaret A Thomas, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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