A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
18 Years and older, Male and Female
R5458-ONC-2012 (primary)
NCI-2022-03373
2020-004638-39
Summary
The study is researching an experimental drug called linvoseltamab in combination with other
drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has
previously been studied as a single agent (without other cancer treatments) in participants
with multiple myeloma that returned after multiple prior therapies and needed to be treated
again.
In the initial study, some participants treated with linvoseltamab had improvement of their
myeloma, including complete responses (no evidence of myeloma in their bodies). This study is
the first time linvoseltamab will be combined with other cancer therapies. The main goal is
to understand if linvoseltamab can be given safely with other cancer treatments, and if so,
what dose of linvoseltamab should be used for each combination.
The study is looking at several other research questions, including:
- How many participants treated with linvoseltamab in combination with each of the other
cancer treatments have improvement of their multiple myeloma
- What side effects may happen from taking linvoseltamab together with another cancer
treatment
- How much study drug is in your blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less
effective or could lead to side effects)
Eligibility
- Eastern Cooperative Oncology Group (ECOG) performance status =1
- Participants must have measurable disease as defined in the protocol according to International Myeloma Working Group (IMWG) consensus criteria
- Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol
- Life expectancy of at least 6 months. Cohort Specific Inclusion Criteria: For the below cohorts, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 proteasome inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD. Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated. However, participants enrolled in the expansion portion cannot be refractory to an anti-CD38 antibody containing regimen. In addition, all participants must have at least a 6-month washout from prior anti-CD38 antibody therapy. Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose. Carfilzomib-refractory participants may enroll in the dose finding portion provided they are triple-class refractory (PI, IMiD, anti-CD38 antibody). However, participants enrolled in the dose expansion portion cannot be refractory to carfilzomib. In addition, all participants must have at least a 6-month washout from prior carfilzomib therapy. Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose. However, a participant cannot be refractory to any combination regimen that included 25 mg of lenalidomide. In addition, participants must have at least a 6-month washout from any prior lenalidomide therapy (including maintenance therapy). Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose. Bortezomib-refractory participants may enroll in the dose finding portion provided they are triple-class refractory (PI, IMiD, anti-CD38 antibody). However, participants enrolled in the dose expansion portion cannot be refractory to bortezomib. In addition, all participants must have at least a 6-month washout from prior bortezomib therapy. Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose. Additionally, participants must undergo at least a 6-month washout following prior pomalidomide therapy before enrollment. Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated. Additionally, participants must undergo at least a 3-month washout following prior anti-CD38 antibody therapy before enrollment. Cohort 7 and 8: RRMM with progressive disease and one of the following:
- Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1IMiD, and 1 PI or
- Triple-class refractory disease (anti-CD38 antibody, IMiD, PI) Cohort 9: each participant must have progressive RRMM and the following:
- Received at least 3 lines of therapy and
- Triple-class refractory disease (anti-CD38 antibody, IMiD, PI)
Treatment Sites in Georgia
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