Phase 3 Clinical Trial Comparing the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance to Approved Lenalidomide Maintenance Alone in Patients with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Stem Cell Transplant

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Overview

This goal of this trial is to compare the safety and effectiveness of investigational Idecabtagene Vicleucel followed by Lenalidomide maintenance to approved Lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who have suboptimal response to autologous stem cell transplant. 

SparkCures ID 1764
Trial Phase Phase 3
Enrollment 618 Patients
Treatments
Tags
Trial Sponsors
  • Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb
Trial Collaborators
  • Bristol Myers Squibb
  • 2Seventy Bio
NCT Identifier

NCT06045806

CLOSED

This trial has terminated.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

* 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.
* 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.
* Participant must have documented response of PR or VGPR at time of consent.
* 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).
* Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

Exclusion Criteria:

* Participant with known central nervous system involvement with myeloma.
* Participant has non-secretory MM.
* Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
* Participant has history of primary immunodeficiency.
* 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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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