Multiple MyelomaPhase 2EMATNCT05690984
Elimination of Minimal Residual Disease After Transplant
A Phase 2 study testing Dexamethasone, Isatuximab and Lenalidomide in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a single-center, single-arm, phase II study that will enroll multiple myeloma (MM) patients with persistent bone marrow minimal residual disease (MRD) post autologous stem cell transplant (ASCT) irrespective of the International Myeloma Working Group (IMWG) response. 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?
- Dexamethasone, Isatuximab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to Aug 2027
- Phase
- Phase 2
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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-2.
- Must have archival bone marrow sample at time of diagnosis that can be used for clonality identification for NGS if not already performed.
- Presence of residual bone marrow minimal residual disease (MRD) positivity by clonoSEQ® next-generation sequencing (NGS) 90-120 days post autologous stem cell transplantation.
- Histologically confirmed diagnosis of symptomatic multiple myeloma (patients with multiple myeloma with secondary amyloidosis are eligible, but no amyloid treatment will be allowed while on study).
- Received autologous stem cell transplant as upfront therapy for myeloma (defined as ASCT within one year of diagnosis of symptomatic MM).
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- Adequate organ function as defined below:
- Absolute neutrophil count (ANC) ≥1,000/mm^3.
- Platelet count ≥75,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within seven days before study enrollment.
- Total bilirubin ≤1.5 x the upper limit of the normal range (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN
- Pregnancy It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Non-sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below.
- Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a female of childbearing potential (FCBP), OR
- A FCBP who must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours prior to starting study medication and before each cycle of study treatment and must either commit to continue abstinence from heterosexual intercourse or apply a highly effective method of birth control during the intervention period and for at least five months after the last dose of isatuximab treatment Male participants: A male participant, even if surgically sterilized (i.e., status post-vasectomy), must agree to use contraception during the intervention period and for at least five months after the last dose of isatuximab treatment and refrain from donating sperm during this period.
- All study participants must be registered into the mandatory Revlimid REMS® program and be willing to comply with its requirements.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Evidence of MM disease progression any time prior to enrollment.
- Administration or planned administration of any other concomitant chemotherapy, immunotherapy, or any ancillary therapy that would be considered a treatment of multiple myeloma from Day +30 post-transplant through discontinuation from study. Local radiation therapy is allowed. Subjects may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.)
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Prior organ transplant requiring immunosuppressive therapy.
- Known to be human immunodeficiency virus (HIV) positive.
- Known to have hepatitis A, B, or C active infection. If hepatitis positive, patient may still be per the notes below.
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- Uncontrolled or active hepatitis B virus (HBV) infection: Patient with positive HBsAg and/or HBV DNA.
- Of Note:
- Patient can be eligible if anti-HBc IgG positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative.
- If anti-HBV therapy in relation with prior infection was started before initiation of investigational medicinal product, the anti-HBV therapy and monitoring should continue throughout the study treatment period.
- Patient with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met.
- Active hepatitis C virus (HCV) infection: positive HCV RNA and negative anti-HCV.
- Of Note:
- Patients with antiviral therapy for HCV started before initiation of investigational medicinal product and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion.
- Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis).
- Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous six months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, severe orthostatic hypotension, or clinically important autonomic disease.
- Major surgery within 14 days prior to start of study treatment (Note: vertebroplasty and kyphoplasty are not considered major surgery).
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to start of study treatment.
- Participation in other clinical trials, including those where a subject received an investigational drug within 30 days or five half-lives of the investigational drug prior to start of study treatment, whichever is longer.
- Any clinically significant, uncontrolled medical conditions that, in the investigator's opinion, would expose the subject to excessive risk or may interfere with compliance or interpretation of the study results.
- Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- Pregnant or breastfeeding subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Combination Post-transplant Consolidation Therapy With Isatuximab, Lenalidomide, Dexamethasone (IsaRD) in Multiple Myeloma Patients With Persistent Marrow Minimal Residual Disease (Elimination of MRD After Transplant; E-MAT)
This is a single-center, single-arm, phase II study that will enroll multiple myeloma (MM) patients with persistent bone marrow minimal residual disease (MRD) post autologous stem cell transplant (ASCT) irrespective of the International Myeloma Working Group (IMWG) response.
Read the detailed description
Thirty study subjects will be enrolled at Froedtert Hospital and the Medical College of Wisconsin Cancer Center. Enrolled subjects will receive a combination of isatuximab, lenalidomide, and dexamethasone (IsaRD) for 12 28-day cycles. The primary objective of this study is to determine bone marrow (BM) MRD ≤1x10^5 negativity rate, as measured by the clonoSEQ® next-generation sequencing (NGS) assay, at the end of 12 months of IsaRD treatment. Other objectives will further assess efficacy, tolerability, and molecular response to the IsaRD regimen.
- Conditions
- Multiple Myeloma
- Being tested
- Dexamethasone, Isatuximab, Lenalidomide
- Keywords
- minimal residual disease, multiple myeloma, next-generation sequencing
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron, Dexasone, Diodex, Hexadrol
Dexamethasone will be used for the double purpose of premedication and therapeutic effect. On Day 1 of Cycle 1, subjects will be administered 40 mg dexamethasone as an IV infusion. On Days 8, 15, 22 of Cycle 1 and Days 1 and 15 of Cycles 2-4, dexamethasone will be given as a single oral dose of 40 mg. For Cycles 5-12, dexamethasone will be given as a single oral dose of 4 mg on Days 1 and 15.
IsatuximabDrug
Also called Sarclisa
Following premedication (if applicable), subjects will be given isatuximab 10 mg/kg body weight as an intravenous (IV) infusion on Days 1, 8, 15, and 22 (i.e., weekly) during Cycle 1 and on Days 1 and 15 (i.e., Q2W) during Cycles 2-12.
LenalidomideDrug
Also called Revlimid
On Days 1-21 for all 12 cycles, lenalidomide will be given to subjects as a single daily oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab in combination with lenalidomide and dexamethasone. | Experimental | The isatuximab, lenalidomide, and dexamethasone (IsaRD) therapy will be administered on an outpatient basis. Receives: Drug: Dexamethasone; Drug: Isatuximab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects who have less than MRD.
Bone marrow MRD negative at a cutoff sensitivity of ≤1x10^5 sequence copies as measured by the clonoSEQ® next-generation sequencing assay at the end of IsaRd treatment.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start26 Jun 2023
- Primary completion19 Aug 2026
- Study completionAug 2027 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabarinath Radhakrishnan, MD, Medical College of Wisconsin
- Investigators
- Sabarinath Radhakrishnan, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690984
- Sponsor's protocol ID
- PRO00046592
- Acronym
- EMAT
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No