LymphomaPhase 2NCT05346809
Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma
A Phase 2 study testing Isatuximab and Standard Procedures in people with Lymphoma and Multiple Myeloma, run by Divaya Bhutani at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma
- What is being tested?
- Isatuximab and Standard Procedures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2023to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Following diagnoses are eligible for inclusion in the study:
- Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse.
- Relapsed/Refractory Hodgkin's disease
- Non-Hodgkin's Lymphomas as follows
- Relapsed/Refractory Diffuse large B cell lymphoma
- Relapsed/Refractory indolent or relapsed/refractory transformed indolent B cell lymphomas as consolidation after second line therapy
Show all 12Show fewer
- 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
- Patients undergoing first ASCT will be eligible for the study.
- Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed.
- Age ≥18 years
- Life expectancy of greater than 6 months.
Who cannot join
- 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.
- Pregnant and Lactating women
- HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
Columbia University
New York, New York, 10032
About this study
Official title: Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma
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.
Read the detailed description
Relapse post-autologous stem cell transplantation (ASCT) remains a major challenge in the treatment of multiple myeloma (MM) and Lymphoma. The immune reconstitution post-ASCT has a major impact on the outcomes of ASCT, however effective methods to improve upon immune reconstitution have not been developed and the use of novel immunomodulators remains relatively unexplored. In addition, numerous studies have demonstrated the profound impact of graft composition on transplant outcomes, but not a single prospective study has addressed this issue successfully. In this study, the investigators intend to test a novel double pronged method of changing the immune repertoire post ASCT by modifying graft composition and improving effector T cell recovery and function post ASCT. In this study, the investigators intend to generate new information on immune modulation post-ASCT. In addition, the CD38 antibodies have not been evaluated as therapy for B-cell non-Hodgkin Lymphoma (NHL). If this study shows significant immunomodulator activity of this approach, cluster of differentiation 38 (CD38) antibodies could be further evaluated in combination with ASCT in NHL.
- Being tested
- Isatuximab, Standard Procedures
- Keywords
- Stem cell transplant
- Medical subject headings
- Lymphoma, Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Also called Sarclisa
Isatuximab in IV form 10 mg/kg doses
Standard ProceduresOther
Standard procedures (standard of care) for transplant
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab and Standard Procedures | Experimental | Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant Receives: Drug: Isatuximab |
| Standard procedures | Experimental | Subjects will receive standard procedures for transplant. Receives: Other: Standard Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total lymphocyte count
Change in total lymphocyte count measured from blood sample
Measured: Day 30
Secondary outcomes (6)
Number of Adverse Events
The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 1 year
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
Measured: Day 30
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
Measured: Up to 1 year
Percentage of activated B and T regulatory cells
Percentage of activated B and T regulatory cells in the peripheral blood
Measured: Up to 1 year
Percentage of activated helper and effector T cells
Percentage of activated helper and effector T cells in the peripheral blood
Measured: Up to 1 year
Percentage of Natural Killer (NK) cells
Percentage of NK cells in the peripheral blood
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start31 Mar 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Divaya Bhutani
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor-investigator, Divaya Bhutani, Columbia University
- Investigators
- Divaya Bhutani, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346809
- Sponsor's protocol ID
- AAAT7444
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05346809
- Acronym / sponsor ID
- AAAT7444
- Keywords
- Stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Divaya BhutaniUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Relapse post-autologous stem cell transplantation (ASCT) remains a major challenge in the treatment of multiple myeloma (MM) and Lymphoma. The immune reconstitution post-ASCT has a major impact on the outcomes of ASCT, however effective methods to improve upon immune reconstitution have not been developed and the use of novel immunomodulators remains relatively unexplored. In addition, numerous studies have demonstrated the profound impact of graft composition on transplant outcomes, but not a single prospective study has addressed this issue successfully. In this study, the investigators intend to test a novel double pronged method of changing the immune repertoire post ASCT by modifying graft composition and improving effector T cell recovery and function post ASCT. In this study, the investigators intend to generate new information on immune modulation post-ASCT. In addition, the CD38 antibodies have not been evaluated as therapy for B-cell non-Hodgkin Lymphoma (NHL). If this study shows significant immunomodulator activity of this approach, cluster of differentiation 38 (CD38) antibodies could be further evaluated in combination with ASCT in NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isatuximab and Standard Procedures | Experimental | Drug: IsatuximabSubjects will receive the study drug Isatuximab in addition to standard procedures for transplant |
| Standard procedures | Experimental | Other: Standard ProceduresSubjects will receive standard procedures for transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Following diagnoses are eligible for inclusion in the study:
- Patients undergoing first ASCT will be eligible for the study.
- Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed.
- Age ≥18 years
- Life expectancy of greater than 6 months.
Key exclusion criteria (6 listed)
- 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.
- Pregnant and Lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsatuximabAlso: SarclisaIsatuximab in IV form 10 mg/kg doses | Drug | Isatuximab and Standard Procedures |
| Standard ProceduresStandard procedures (standard of care) for transplant | Other | Standard procedures |
Primary outcome
Change in the total lymphocyte count
Time frame: Day 30
Change in total lymphocyte count measured from blood sample
6 secondary outcomes
Number of Adverse Events
Time frame: Up to 1 year
Percentage of participants with absolute lymphocyte count >500 cells/microliter
Time frame: Day 30
CD8 and CD4 Subsets
Time frame: Up to 1 year
Percentage of activated B and T regulatory cells
Time frame: Up to 1 year
Percentage of activated helper and effector T cells
Time frame: Up to 1 year
Percentage of Natural Killer (NK) cells
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Divaya Bhutani principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab and Standard Procedures in people with Lymphoma and Multiple Myeloma, run by Divaya Bhutani at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the total lymphocyte count (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.