Study on Talquetamab and Lenalidomide for Maintenance Therapy After Stem Cell Transplant in Multiple Myeloma
Sponsor: Stanford University
ClinicalTrials ID:NCT06461988
This clinical trial is exploring the use of two drugs, Talquetamab and Lenalidomide, as a maintenance treatment for patients with multiple myeloma who have undergone a stem cell transplant. The study aims to evaluate the effectiveness and safety of this combination therapy.
Patient Parameters
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Program Overview
Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. This study is testing whether a combination of two drugs, Talquetamab and Lenalidomide, can help maintain remission in patients who have had a stem cell transplant as part of their initial treatment. The trial will involve 30 participants who meet specific criteria and will assess the safety, effectiveness, and impact on quality of life of this treatment approach.
Description
This phase 2 study is designed to evaluate how well the combination of Talquetamab and Lenalidomide works as a maintenance therapy for patients with multiple myeloma who have undergone a stem cell transplant. The study will enroll 30 participants who have either completed or are planning to undergo a stem cell transplant as part of their initial treatment for multiple myeloma. Researchers will monitor the safety of the treatment, as well as any changes in symptoms and quality of life reported by the participants over time.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of symptomatic multiple myeloma.
- Must have measurable disease at the time of diagnosis, defined by specific protein levels in the blood or urine.
- Must be 18 years or older.
- If already received a transplant, it must have been an autologous stem cell transplant within 12 months of starting initial therapy, and the patient must be within 60-120 days post-transplant.
- Must not be resistant to Lenalidomide.
- Must not have worsening disease before joining the study.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must meet specific blood and organ function criteria based on lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 100 days after the last dose.
- Men must agree to use a condom during the study and for 100 days after the last dose.
- Must be willing to follow study procedures and return for follow-up visits.
Exclusion Criteria
- Cannot tolerate Lenalidomide at specified doses.
- Have had relapsed or resistant multiple myeloma before joining the study.
- Have severe allergies or intolerances to any study drugs.
- Have received certain other cancer treatments within specified time frames before the study.
- Have active central nervous system involvement or certain other blood disorders.
- Have had other active cancers within the last 24 months, with some exceptions.
- Have had a stroke or seizure within 6 months before joining the study.
- Are pregnant, breastfeeding, or planning to become pregnant or father a child during the study or within 100 days after the last dose.
- Have certain heart conditions or recent heart events.
- Have active infections or certain viral infections like hepatitis B or C.
- Have had major surgery within 2 weeks before starting the study treatment.
- Have other medical or psychiatric conditions that could interfere with the study or pose a risk to the participant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94304 | Palo Alto | California |
| New Mexico Cancer Research Alliance | 87102 | Albuquerque | New Mexico |
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