Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
EXCALIBER-Maintenance
Clinical summary
Summary
This study is comapring the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in people with newly diagnosed multiple myeloma.
Eligible participants will be randomly allocated to one of four treatment arms.
- Arm A1 (Experimental) will receive Iberdomide Dose 1
- Arm A2 (Experimental) will receive Iberdomide Dose 2
- Arm A3 (Experimental) will receive Iberdomide Dose 3
- Arm B (Active Comparator) willr eceive Lenalidomide
Conditions
This trial is treating people with newly diagnosed multiple myeloma
Eligibility
Inclusion
- Confirmed diagnosis of symptomatic multiple myeloma (MM).
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
- Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
- Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.
Exclusion
- Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
- Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- Known central nervous system/meningeal involvement of MM.
- Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT05827016 *
- IM048-022; 2022-501515-14; U1111-1280-9492
Trial sponsor
Bristol-Myers Squibb
Scientific Title
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information