Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
BMS Recruiting Study icon

Recruiting

Trial ID CA089-1043  |   NCT06045806

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 172
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
    1. Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
      1. Participant must have documented response of PR or VGPR at time of consent.
        1. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
          1. Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

            Exclusion Criteria

            Exclusion Criteria Icon
            • Participant with known central nervous system involvement with myeloma.
              1. Participant has non-secretory MM.
                1. Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
                  1. Participant has history of primary immunodeficiency.
                    1. Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
                      Additional Information *
                      • Other protocol-defined Inclusion/Exclusion criteria apply.

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm A

                        ASSIGNED INTERVENTION
                        • Biological: idecabtagene vicleucel
                        • Drug: Cyclophosphamide, Fludarabine, Lenalidomide

                        Study Arms

                        Active Comparator: Arm B

                        ASSIGNED INTERVENTION
                        • Drug: Lenalidomide
                        Take the first step to see if you Match to a Clinical Trial – Check if you qualify
                        Check if you qualify
                        Answer some questions about Your health to see if you may match to this trial
                        Match to a Trial
                        If you are a match, click on the study to see the list of study site locations
                        Select a Study Site Location
                        Select a study site location that is convenient for you
                        Register
                        Provide your contact details for the study site to connect with you.

                        Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you