Actively Recruiting
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Led by Stanford University · Updated on 2025-08-24
20
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
J
Janssen Scientific Affairs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.
CONDITIONS
Official Title
Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria
- Measurable disease at diagnosis defined by specific serum or urine markers
- Age over 18 years
- Had autologous stem cell transplant with Melphalan within 12 months or planning transplant with induction started within 12 months
- Not refractory to lenalidomide
- No progressive disease before study registration
- ECOG Performance Status score of 0 or 1
- Adequate laboratory values for hemoglobin, platelets, neutrophils, liver enzymes, creatinine clearance, bilirubin, and calcium
- Negative pregnancy test for women of childbearing potential
- Women must use effective contraception or practice abstinence as defined
- Women must agree not to donate eggs during study and 100 days after
- Men must use condoms with spermicidal method and not donate sperm during study and 100 days after
- Willing and able to follow lifestyle restrictions including not donating blood
- Signed informed consent and willing to return for follow-up
You will not qualify if you...
- Intolerance to lenalidomide
- Refractory or relapsed multiple myeloma before enrollment
- Allergies or intolerance to study drugs or excipients
- Prior therapies including GRPRCD5-directed therapy, T-cell redirection therapy, gene-modified adoptive cell therapy within 3 months, recent investigational drugs or vaccines, monoclonal antibodies, cytotoxic or radiotherapy within specified time frames
- High cumulative corticosteroid use before study
- Active CNS involvement of multiple myeloma
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis
- Active other malignancies except specified low-risk treated cancers
- Stroke, seizure, or transient ischemic attack within 6 months
- Pregnant, breastfeeding, or planning pregnancy during study and 100 days after
- Planning to father a child during study and 100 days after
- Specified serious cardiac conditions
- Positive HIV or active hepatitis B or C infection
- Major surgery within 2 weeks before or planned during study
- Concurrent medical or psychiatric conditions interfering with study or posing hazard such as uncontrolled diabetes, active infections, certain autoimmune diseases, or severe psychiatric disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
B
Brent LaStofka
CONTACT
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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