Multiple MyelomaPhase 2HEME-18NCT05344833
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
A Phase 2 study testing Isatuximab and Lenalidomide in people with Multiple Myeloma, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Isatuximab and Lenalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2023to Dec 2030
- 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
- Age > 18 years
- Patients must have a confirmed diagnosis of multiple myeloma according to IMWG criteria. Patients with smoldering multiple myeloma, or plasma cell leukemia are not eligible. Patients must not have significant amyloid organ dysfunction per the study chair.
- R-ISS stage 1, 2 or 3 at diagnosis. If stage at diagnosis is not known, patient may be enrolled if the intent is to treat with post -ASCT maintenance therapy.
- Received up to or less than 2 lines of therapy prior to ASCT (as long as they did not meet IMWG refractory disease for CD38 monoclonal antibody or lenalidomide therapies as defined in exclusion).
- Patients are planned to undergo ASCT with high dose melphalan, or have completed ASCT with high dose melphalan within the last 180 days and have not yet initiated post-ASCT maintenance.
- Obtain at least partial response according to IMWG criteria prior to autologous stem cell transplant
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- ECOG performance status of 0, 1, or 2 within 30 days prior to enrollment.
- Demonstrate adequate organ function as defined in the table below; all screening labs are to be obtained within 30 days prior enrollment.
- Hematologic White blood cell (WBC) ≥ 1500/mm3 Absolute Neutrophil Count (ANC) ≥ 1000/mm3 Platelets ≥ 50,000/mm3 Renal Calculated creatinine clearance ≥ 30 mL/min using either the Cockcroft-Gault formula or estimated GFR, and not requiring continuous or intermittent dialysis Hepatic Bilirubin ≤ 2.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT)1 ≤ 2 × ULN Note: Patients on anticoagulation are exempt from meeting this criterion
- Standard of care lenalidomide will not be provided by the sponsor or study and therefore study subjects must have confirmed access to lenalidomide for use during the study at the time of enrollment.
- Must be able to take and swallow oral medication (capsules) whole. Patients may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 5 months for females, and 1 month for males after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. Interventions such as IUD, tubal ligation, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, all count as one method. For women of childbearing potential (WOCBP), a second form must also be used. Men must agree to use a latex condom during sexual activity with a female of childbearing potential, irrespective of a prior vasectomy, during the study treatment and for 1 month after the end of treatment. Females of childbearing potential agree to not plan a pregnancy for 1 month after the last dose of study medication. Females of childbearing potential must agree to ongoing pregnancy testing during the treatment period.
- NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
- Patients must be willing to take appropriate DVT prophylaxis, either aspirin, low molecular weight heparin, direct oral anticoagulants, or warfarin while receiving lenalidomide.
Who cannot join
- Refractory to anti-CD38 monoclonal antibody therapy OR lenalidomide as defined by the IMWG (defined as non-responsive or progressive disease on therapy or within 60 days of last treatment).
- Prior intolerance to isatuximab or lenalidomide.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant requiring immunosuppressive therapy.
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- Known CNS involvement by multiple myeloma, defined by positive CSF cytology for plasma cells, leptomeningeal involvement, or parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
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- Treatment with any investigational drug within 30 days prior to enrollment.
- Planned transplant is considered part of tandem autologous transplant approach for newly diagnosed MM.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or coronary angioplasty, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] v5.0 Grade ≥ 2), intracardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (≥ Grade 3), or known psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because lenalidomide is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide.
- Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with active treatment and absolute lymphocyte count ≥ 350/ul. Antiviral therapy for HIV should continue throughout the study.
- Patients with a positive test for hepatitis B virus surface antigen (HBsAg) and/or HBV DNA indicating uncontrolled or active HBV infection. Patients with negative HBsAg and positive HBV viral load can be evaluated by a specialist for start of anti-viral therapy and study treatment can be proposed if HBV viral load becomes negative and other study criteria are met. Participants can be eligible if anti-HBc IgG is positive, but HBsAg and HBV viral load is negative (i.e., cleared infection).
- Patients with known hepatitis C virus (HCV) viral load indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment. If a patient was started on antiviral therapy prior to study enrollment, antiviral therapy should continue throughout the study.
- NOTE: HIV, Hep B, and Hep C viral testing is not required and this criterion apply only to patients with a known history of HCV infection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Sweiss Karen, PharmD, 312-996-0875, ksweis2@uic.edu
Marisol Vega, MS, 312-355-5035, vegam35@uic.edu
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Douglas Sborov, MD, 801.585.3229, douglas.sborov@hci.utah.edu
Mia Kowalczyk, 801.585.0303, mia.kowalczyk@hci.utah.edu
About this study
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Read the detailed description
This is a phase II study where patients will undergo isatuximab and lenalidomide-based maintenance if they are MRD-positive after ASCT. Patients may have received equal to or less than 2 lines of induction therapy prior to ASCT. Patients will be enrolled at any time prior to ASCT or up to day 180 after ASCT.Patients will undergo disease reassessment per standard of care including BM examination and MRD testing by NGS at day 90 (+/- 30 days) of ASCT. All patients in MRD-negative (defined as 10-6) CR will be treated off study with lenalidomide monotherapy and all patients who are MRD-positive will begin treatment with isatuximab and lenalidomide, starting any time after MRD results are obtained (treatment must commence before day 180 of ASCT).Patients will be monitored for disease response and every 12 months for BM MRD status, for a total of 3 years, or until disease progression or unacceptable toxicity meeting criteria for protocol removal.
- Conditions
- Multiple Myeloma
- Being tested
- Isatuximab, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39.
LenalidomideDrug
Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab and Lenalidomide Maintenance | Experimental | All participants will receive:
Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. Lenalidomide 10mg PO Days 1-21 Cylces 1-3 (all cycles 28 days) Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression. Receives: Drug: Isatuximab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have MRD-negative CR rate, defined as 10-6
Evaluate the number of participants that have MRD-negative at 1 year that were MRD-positive multiple myeloma (MM) treated with isatuximab and lenalidomide based maintenance after ASCT
Measured: 1 year
Secondary outcomes (10)
Observed length of time of progressive free survival (PFS)
Number of days participants remain PFS
Measured: 3 years
Observed length of time of overall survival (OS)
Number of days participants remain OS
Measured: 3 years
Number of participants that achieve a deeper MRD-negative CR rate, defined as 10-6
Evaluate the number of participants that achieve a deeper MRD-negative at 1 year that were MRD-positive in MM treated with isatuximab and lenalidomide based maintenance after ASCT
Measured: 1 year
Number of participants that convert from MRD-positive to MRD-negative disease status in MM patients
Evaluate number of participants that convert from MRD-positive to MRD-negative disease status in MM patients receiving isatuximab and lenalidomide based maintenance
Measured: 3 years
Number of participants that have an International Myeloma Working Group (IMWG) defined response rate of MM patients receiving isatuximab and lenalidomide based maintenance
Evaluate the number of participants that have an IMWG defined response rate
Measured: 3 years
Number of participants that have MRD-negative CR rates of MM patients receiving isatuximab and lenalidomide based maintenance
Evaluate the number of participants that have MRD-negative CR rates
Measured: 3 years
Number of occurrences of treatment-related adverse events (AE) in MM patients receiving isatuximab and lenalidomide based maintenance
Evaluate the number of occurrences of treatment-related AES
Measured: 3 years
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Complete European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-C30 questionnaire at 3 years. The higher the score the worse the subject's health is and the lower the score the better the subject's health is
Measured: 3 years
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Complete European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Multiple Myeloma Module at 3 years. The higher the score the worse the subject's health is and the lower the score the better the subject's health is and the lower the score the better the subject's health is
Measured: 3 years
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Complete European Quality of Life Five Dimensions Questionnaire-5-level at 3 years. The higher the score the worse the subject's health is and the lower the score the better the subject's health is
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start5 Jan 2023
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Huntsman Cancer Institute
- Responsible party
- Principal investigator, Karen Sweiss, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344833
- Sponsor's protocol ID
- 2021-1101
- Acronym
- HEME-18
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2022
- Last updated
- 28 Aug 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05344833
- Acronym / sponsor ID
- HEME-18 / 2021-1101
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Huntsman Cancer Institute
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 25 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.
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Detailed description
This is a phase II study where patients will undergo isatuximab and lenalidomide-based maintenance if they are MRD-positive after ASCT. Patients may have received equal to or less than 2 lines of induction therapy prior to ASCT. Patients will be enrolled at any time prior to ASCT or up to day 180 after ASCT.Patients will undergo disease reassessment per standard of care including BM examination and MRD testing by NGS at day 90 (+/- 30 days) of ASCT. All patients in MRD-negative (defined as 10-6) CR will be treated off study with lenalidomide monotherapy and all patients who are MRD-positive will begin treatment with isatuximab and lenalidomide, starting any time after MRD results are obtained (treatment must commence before day 180 of ASCT).Patients will be monitored for disease response and every 12 months for BM MRD status, for a total of 3 years, or until disease progression or unacceptable toxicity meeting criteria for protocol removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isatuximab and Lenalidomide Maintenance | Experimental | Drug: Isatuximab, Drug: LenalidomideAll participants will receive: Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. Lenalidomide 10mg PO Days 1-21 Cylces 1-3 (all cycles 28 days) Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age > 18 years
- Patients must have a confirmed diagnosis of multiple myeloma according to IMWG criteria. Patients with smoldering multiple myeloma, or plasma cell leukemia are not eligible. Patients must not have significant amyloid organ dysfunction per the study chair.
- R-ISS stage 1, 2 or 3 at diagnosis. If stage at diagnosis is not known, patient may be enrolled if the intent is to treat with post -ASCT maintenance therapy.
- Received up to or less than 2 lines of therapy prior to ASCT (as long as they did not meet IMWG refractory disease for CD38 monoclonal antibody or lenalidomide therapies as defined in exclusion).
- Patients are planned to undergo ASCT with high dose melphalan, or have completed ASCT with high dose melphalan within the last 180 days and have not yet initiated post-ASCT maintenance.
Key exclusion criteria (14 listed)
- Refractory to anti-CD38 monoclonal antibody therapy OR lenalidomide as defined by the IMWG (defined as non-responsive or progressive disease on therapy or within 60 days of last treatment).
- Prior intolerance to isatuximab or lenalidomide.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant requiring immunosuppressive therapy.
- Known additional malignancy that is active and/or progressive requiring treatment; exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
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 |
|---|---|---|
| IsatuximabIsatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. | Drug | Isatuximab and Lenalidomide Maintenance |
| LenalidomideLenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression. | Drug | Isatuximab and Lenalidomide Maintenance |
Primary outcome
Number of participants that have MRD-negative CR rate, defined as 10-6
Time frame: 1 year
Evaluate the number of participants that have MRD-negative at 1 year that were MRD-positive multiple myeloma (MM) treated with isatuximab and lenalidomide based maintenance after ASCT
10 secondary outcomes
Observed length of time of progressive free survival (PFS)
Time frame: 3 years
Observed length of time of overall survival (OS)
Time frame: 3 years
Number of participants that achieve a deeper MRD-negative CR rate, defined as 10-6
Time frame: 1 year
Number of participants that convert from MRD-positive to MRD-negative disease status in MM patients
Time frame: 3 years
Number of participants that have an International Myeloma Working Group (IMWG) defined response rate of MM patients receiving isatuximab and lenalidomide based maintenance
Time frame: 3 years
Number of participants that have MRD-negative CR rates of MM patients receiving isatuximab and lenalidomide based maintenance
Time frame: 3 years
Number of occurrences of treatment-related adverse events (AE) in MM patients receiving isatuximab and lenalidomide based maintenance
Time frame: 3 years
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Time frame: 3 years
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Time frame: 3 years
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Time frame: 3 years
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 28 Aug 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.
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 Lenalidomide in people with Multiple Myeloma, run by University of Illinois Chicago 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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 Aug 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?
Contact Karen Sweiss, PhD (312-996-0875, ksweis2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that have MRD-negative CR rate, defined as 10-6 (time frame: 1 year). 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 28 Aug 2026.