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
This 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 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 the 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) General Key
Treatment Sites in Georgia
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