Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
US Oncology Research
Study ID
NCT04782687
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Kahler Disease
  • Multiple Myeloma
  • Myeloma Multiple
  • Myeloma, Plasma Cell
  • Myeloma-Multiple
  • Myelomatosis
  • Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    oral drug that comes in 20 mg tablets
  • Dexamethasone Oral — DRUG
    Dexamethasone 40 mg on Days 1, 8, 15, 22 of each cycle. However, those \>75 years old may be administered a weekly dose of 20 mg dexamethasone.
  • Daratumumab — DRUG
    Patients will receive daratumumab subcutaneously (SC, or under the skin) as an injection. The recommended dosage of the SC formulation is 1,800 mg daratumumab and 30,000 units hyaluronidase administered SC into the abdomen over approximately 3 to 5 minutes according to recommended schedule. Daratumumab 1800 mg subcutaneously once weekly in Cycles 1 and 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter.
  • Lenalidomide — DRUG
    Patients will receive a 21-day supply of lenalidomide (15 mg) as oral capsules, as appropriate, for each 28-day treatment cycle

Study Details

This is a single-arm, phase II, open-label trial to investigate the effects of selinexor (S) in combination with daratumumab, lenalidomide, and dexamethasone (DRd) for first-line treatment of multiple myeloma (MM). FDA has approved selinexor plus dexamethasone in multiple myeloma after four prior therapies, and DRd is also already approved by the FDA for multiple myeloma. This study will use all four (S-DRd) together to treat MM as an initial treatment.

Key Dates

Start date
Sep 10, 2021
Status verified
Jan 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
73 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor plus DRd
    1. Lenalidomide 15 mg orally on Days 1-21 of each 28-day cycle 2. Dexamethasone 40 mg on Days 1, 8, 15, 22 of each cycle. However, those \>75 years old may be administered a weekly dose of 20 mg dexamethasone. 3. Daratumumab 1800 mg subcutaneous injection once weekly in Cycles 1 and 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter. 4. Selinexor 60 mg on Days 1, 8, 15, of cycles 1-3, with a planned dose-reduction to 40 mg on Days 1, 8, 15 for cycles beyond 3. If patient was previously dose reduced prior to cycle 4, then at cycle 4 planned dose reduction, you will again decrease dose by 1 level.

Primary Outcome Measure

Complete Response Rate (CR) [ Time Frame: 6 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates, PC - HOPETucsonArizona85711-
Rocky Mountain Cancer CentersDenverColorado80218-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
New York Oncology Hematology, P.C.AlbanyNew York12206-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Texas Oncology, P.A.AustinTexas78705-
Texas Oncology, P.A.Fort WorthTexas76104-
Texas Oncology, P.A.San AntonioTexas78240-
Texas Oncology, P.A.TylerTexas75702-
Virginia Cancer Specialists, PCGainesvilleVirginia20155-

Find similar trials in Tucson, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Arizona Oncology Associates, PC - HOPE· Tucson, AZRocky Mountain Cancer Centers· Denver, COMaryland Oncology Hematology, P.A.· Columbia, MDNew York Oncology Hematology, P.C.· Albany, NYWillamette Valley Cancer Institute and Research Center· Eugene, ORTexas Oncology, P.A.· Austin, TX

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