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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

Status
Active
Cancer Type
Multiple Myeloma
Plasma cell neoplasm
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06045806
Protocol IDs
CA089-1043 (primary)
NCI-2024-01211
2022-501346-30
U1111-1280-9736
Study Sponsor
Celgene

Summary

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).

Eligibility

  1. 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.
  2. 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.
  3. Participant must have documented response of PR or VGPR at time of consent.
  4. 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).
  5. Participant must have recovered to = Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.