Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06876142
Phase
PHASE1/PHASE2
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib — DRUG
    Capsules taken by mouth twice a day (2-12mg) for days 1-21 days of each 28 day cycle
  • Sirolimus — DRUG
    Tablets taken by mouth once a day for days 1-28 days of each 28 day cycle. Loading dose of 12 mg on Day 1 Cycle 1 with 4 mg being taken for the remaining doses.

Study Details

Background: Multiple myeloma (MM) is a type of blood cancer that affects a person s immunity. MM returns after treatment (relapse) in almost all people; MM may also not respond to initial treatment (refractory). Many people with relapsed refractory MM (RRMM) also have changes in their KRAS and NRAS genes. Researchers want to try a new drug treatment that targets cancer with these changed genes. Objective: To test 2 drugs (mirdametinib and sirolimus) in people with RRMM. Eligibility: People aged 18 and older with RRMM who have changes in their KRAS or NRAS genes. Design: Participants will be screened. They will have blood tests and imaging scans. They will have an eye exam and a test of their heart function. They will need to provide proof of their disease status and of their KRAS or NRAS status. If neither is available, the tests will be repeated. Participants will have a bone marrow biopsy: A needle will be inserted into a hipbone to draw out some soft tissue. This study will be done in two parts. In the first part of this study, we will find a safe dose of mirdametinib combined with sirolimus. In the second part, we will learn more about how mirdametinib combined with sirolimus may work against RRMM. Mirdametinib (capsules) and sirolimus (tablets) are taken by mouth. Participants will take both drugs at home on a 4-week cycle. They will take mirdametinib twice a day for the first 3 weeks of each cycle. They will take sirolimus once a day, every day, during each cycle. Participants will have study visits once a week during the first cycle, and then on the first day of subsequent cycles. Blood, heart, imaging scans, and other tests will be repeated. Treatment with the study drugs will go on for 1 year. Then participants will have follow-up visits every 3 months for 4 more years.

Key Dates

First listed
Mar 14, 2025
Start date
Jul 20, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2033
Completion
Jan 1, 2033

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Sirolimus and escalating doses of mirdametinib
  • Experimental: Arm 2
    Sirolimus and RP2D of mirdametinib

Primary Outcome Measure

Phase 1: determine the RP2D of the mirdametinib in combination with sirolimus in participants with RAS-mutated RRMM [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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