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Sirolimus Pre-conditioning for Multiple Myeloma

This study is looking at a new way to treat multiple myeloma, a type of blood cancer. It's testing if giving a drug called sirolimus first, before other treatments, can make those treatments work better. The other treatments are T-cell engaging bispecific antibodies, specifically teclistamab and talquetamab. These antibodies help your own immune cells (T-cells) find and kill cancer cells. Researchers want to see if sirolimus can improve how well these T-cells work. The study will also look at how safe this approach is. You could be eligible if you are 18 or older and have been diagnosed with multiple myeloma. The study is currently recruiting about 10 participants.

Study design
This is a single-center, single-arm Phase Ib study with an expansion cohort, meaning all participants will receive the same treatment and there are about 10 participants planned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for 30 days after the last dose of study treatment, and changes in T-cell ratios will be measured for up to 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07581704

Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Christopher Strouse
~10 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:SirolimusTeclistamabTalquetamb

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured over From treatment initiation through 30 days post last dose of study treatment
+1 more outcome measured

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Christopher Strouse, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Christopher Strouse, MD
[email protected]
(319) 356-0489
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Willingness and ability to provide signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Aged 18 years of older.
Diagnosis with multiple myeloma, per IMWG Consensus Criteria.20
Planned for treatment with teclistamab, or talquetamab per standard of care, label indications.15
Prior exposure to any of the following types of T-cell engaging therapies.
Required clinical laboratory values during screening phase
Ability to take oral medication and be willing to adhere to the sirolimus pre-conditioning regimen.
ECOG performance status of 0, 1, or 2 (KPS of \>50).
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner per section5.3.
Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.

Exclusion

Participants whose multiple myeloma is progressing at a rapid pace requiring immediate anti-myeloma therapy per assessment by the principal investigator or enrolling investigator are excluded.
Excluded concomitant medication exposures:
Exposure to corticosteroids within 1 week of treatment start
Exposure to calcineurin inhibitor or mTOR inhibitors (tacrolimus, everolimus, temsirolimus, sirolimus)
Immunomodulatory monoclonal antibodies targeting tumor necrosis factor alpha (e.g. infliximab), interleukin 6 (e.g. siltuximab),
Janus kinase inhibitors (e.g. ruxolitinib)
Any other investigational drug within 28 days
History of allogeneic hematopoietic cell transplantation.
Excluded concurrent medical conditions:
Active uncontrolled infection within 7 days prior to treatment start
Uncontrolled thrombotic event within 3 months of treatment start
Acute myocardial infarction or acute coronary syndrome within 6 months of start of treatment
Uncontrolled inflammatory bowel disease
Active hepatitis B virus, hepatitis C virus, or Human Immunodeficiency Virus infection
Uncontrolled rheumatologic conditions
Use of ACE-inhibitor therapy within 1 week of treatment start
Patients found to be taking ace-inhibitor therapy during screening can be included if the ace-inhibitor is substituted for an angiotensin receptor blocking agent. (https://drug-interactions.medicine.iu.edu/main-table)
CYP3A4/p-gp inhibitors and inducers for 7 days prior to sirolimus doses and 7 days after sirolimus doses(see appendix A for list)
Any other current active malignancy or history of metastatic malignancy that has the potential to interfere with the safety or efficacy assessment of the investigational intervention
Pregnancy or lactation.
Known allergic reactions to study agent (sirolimus).

What this trial measures

  • Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0From treatment initiation through 30 days post last dose of study treatment

    The incidence of treatment-emergent adverse events will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on NCI CTCAE v5.0) grades), and relation to study treatment. The most severe grade per participant will be reported. Adverse events leading to premature discontinuation from the study intervention and serious treatment-emergent adverse events will be presented in tabular form.

  • Expansion Cohort: Participants change in the Teffector: Texhausted cell ratioFrom treatment initiation through 3 months

    Testing the null hypothesis H0: ΔPost-Pre = 0 versus the alternative H1: ΔPost-Pre ≠ 0. Results will be used as preliminary estimates to inform a subsequent larger trial.