Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06207799
Phase
PHASE2
Status
Recruiting

Conditions

  • Multiple Myeloma
  • Post-transplant MRD-guided Maintenance Therapy
  • Pre-transplant Purging

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    Given by SC
  • Lenalidomide — DRUG
    Given by PO
  • Plerixafor — DRUG
    Given by SC
  • Melphalan — DRUG
    Given by IV
  • Busulfan — DRUG
    Given by PO
  • G-CSF — DRUG
    Given by IV
  • Stem cell transplant — PROCEDURE
    Given by IV

Study Details

To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.

Key Dates

Start date
Jul 17, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elranatamab
    1. Induction therapy - This is given to decrease the number of MM cells in the bone marrow. 2. Purging - This is done to remove leftover MM cells after induction therapy. 3. Stem cell mobilization - This is done to move stem cells from your bone marrow into the blood, so they can be collected for the autologous stem cell transplant. 4. Conditioning therapy - This is given to help prepare the body to receive the stem cell transplant. 5. Autologous stem cell transplant 6. Maintenance therapy - This is given to help control the disease after the stem cell transplant.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Qaiser Bashir, MD
713-794-4422
Qaiser Bashir, MD (PRINCIPAL_INVESTIGATOR)

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