Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDivaya Bhutani
About this trial
The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Relapsed/Refractory Diffuse large B cell lymphoma
Relapsed/Refractory indolent or relapsed/refractory transformed indolent B cell lymphomas as consolidation after second line therapy
Mantle Cell lymphoma as consolidation after first-line therapy
Peripheral T cell lymphoma as consolidation after first-line therapy or at relapse or primary refractory disease
Disqualifiers
Previously exposure to a CD38 antibody during the last 12 months.
Participants who are receiving any other investigational agents concurrently or received any investigational agent within the last 8 weeks.
History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial design
Design model
Parallel
Treatments tested in this trial
Isatuximab
DrugIsatuximab in IV form 10 mg/kg doses
Standard Procedures
Other interventionStandard procedures (standard of care) for transplant
Treatment groups
39 Participants
are divided into 2 treatment groupsGroup A: Isatuximab and Standard ProceduresExperimental treatment 1 intervention
Group B: Standard proceduresExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in the total lymphocyte count
Change in total lymphocyte count measured from blood sample
Time frame
Day 30Secondary outcomes
1
Number of Adverse Events
The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Up to 1 year2
Percentage of participants with absolute lymphocyte count >500 cells/microliter
Percentage of participants with an absolute lymphocyte count of \>500 cells/microliter on Day 30 post transplant
Time frame
Day 303
CD8 and CD4 Subsets
Immune cell phenotyping ( cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) subsets) in the peripheral blood using flow cytometry based analysis
Time frame
Up to 1 year4
Percentage of activated B and T regulatory cells
Percentage of activated B and T regulatory cells in the peripheral blood
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Divaya Bhutani
Lead sponsor
Columbia University
Sponsor institution
Genzyme, a Sanofi Company
Collaborator
Source ClinicalTrials.gov