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Smoldering Plasma Cell MyelomaPhase 2NCT02960555

Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)

A Phase 2 study testing Isatuximab and Laboratory Biomarker Analysis in people with Smoldering Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-center, open label, phase II study designed to evaluate the efficacy of isatuximab with or without lenalidomide when given to patients with high risk smoldering multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoldering Plasma Cell Myeloma
What is being tested?
Isatuximab and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
3 sitesUnited States
Study dates
8 Feb 2017to 30 Apr 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

  • -Risk factors for progression to multiple myeloma in patients with smoldering multiple myeloma (SMM) have been identified and include: percentage of bone marrow involvement by plasma cells, monoclonal spike in blood, serum free light chains in blood, presence or absence of immunoparesis in blood, percentage of normal versus abnormal plasma cells in the bone marrow compartment by using standard flow cytometry techniques and gene expression profiling of plasma cells obtained from a bone marrow aspirate.
  • Patients must have histologically confirmed SMM based on the following criteria. Both criteria must be met:
  • Serum monoclonal protein (IgG or IgA) ≥ 3 g/dL or urinary monoclonal protein ≥ 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%
  • Absence of myeloma defining events or amyloidosis
  • Additionally, patients must meet criteria for high risk of progression to multiple myeloma by PETHEMA criteria (patients must have at least 2 risk factors present) (11):
  • ≥95% abnormal plasma cells/total plasma cells in bone marrow compartment. (This is measured as a percentage of the total abnormal versus normal plasma cells in the bone marrow compartment using standard flow cytometry of the bone marrow aspirate. Having ≥95% abnormal plasma cells/total plasma cells constitutes a risk factor for progression to multiple myeloma by PETHEMA criteria)
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  • Immunoparesis (This term refers to the patient having low uninvolved immunoglobulins in peripheral blood, for example if a patient has IgA smoldering multiple myeloma, then either having a low IgM and/or low IgG will qualify as a risk factor for progression to multiple myeloma)
  • 2 of 2 risk factors: high risk for progression at a rate of 72% at 5 years
  • Creatinine clearance (CrCl) ≥ 40 ml/min. CrCl will be calculated using the Modification of Diet in Renal Disease (MDRD) equation.
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of isatuximab in patients <18 years of age, children are excluded from this study.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109 /L, hemoglobin more or equal than 2 grams below the institutional level of normal and platelet count ≥ 90 x 109/L. Platelet and blood transfusions are allowed on protocol. Growth factors, including granulocyte colony stimulating factors and erythropoietin are allowed.
  • Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 3.0 x ULN.
  • Females of childbearing potential and male subjects with female partners of childbearing potential must agree to avoid pregnancy by using an adequate method of contraception (2 barrier method or 1 barrier method with a spermicide or intrauterine device for 10-14 days prior to screening, during and 5 months after the last dose of isatuximab. Adequate methods of contraception are provided as examples. Other acceptable and effective methods of birth control are also permitted (eg, abstinence).
  • Men must agree to not donate sperm while on the study and for at least 5 months after the last dose of isatuximab. Women of child bearing potential must have a negative serum/urine pregnancy test result within 10-14 days prior to the first administration of isatuximab and at the end of treatment visit. A negative urine pregnancy test is required prior to each subsequent isatuximab dose administration.
  • Subjects must be able to give informed consent.

Who cannot join

  • Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following(14)
  • Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)
  • Renal Insufficiency: creatinine clearance < 50 ml/min or serum creatinine > 2 mg/dL
  • Anemia: hemoglobin value <10 g/dL or 2 g/dL < normal reference
  • Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT).
  • Clonal bone marrow plasma cell percentage ≥ 60%
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  • Involved: uninvolved serum free light chain ratio ≥100 measured by Freelite assay (The Binding Site Group, Birmingham, UK)
  • >1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
  • Bisphosphonates are permitted, including pamidronate, zoledronic acid, alendronate, ibandronate, risedronate.
  • Treatment with corticosteroids is not permitted, unless the patient is on a stable chronic dose of inhaled steroids to treat respiratory diseases or on stable chronic steroid replacement therapy for endocrinology disorders.
  • Radiotherapy is not permitted.
  • Prior or concurrent treatment for smoldering multiple myeloma with chemotherapy agents approved for the treatment of smoldering multiple myeloma or CD38 drugs is not permitted.
  • Plasma cell leukemia
  • Pregnant or lactating females. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with isatuximab, breastfeeding should be discontinued if the mother is treated with isatuximab. These potential risks may also apply to other agents used in this study.
  • Active hepatitis B or C infection
  • Known HIV infection
  • Intolerance to infused protein products, sucrose, histidine or polysorbate 80
  • Concurrent treatment with other anti-cancer therapy is not permitted
  • Patients must not have uncontrolled intercurrent illness including hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia. Patients should not have New York Heart Association classification III or IV heart failure at baseline.
  • Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
  • Contraindication to any concomitant medication, including pre-medications or hydration given prior to therapy
  • Major surgery within 1 month prior to enrollment
  • Patients with pre-existing pulmonary uncontrolled disease will be excluded. Uncontrolled refers to patients having had at least one hospitalization due to pulmonary disease (for example, asthma, chronic obstructive pulmonary disease) within the 6 months prior to enrollment in the study. Patients with previous history of pneumonitis will be excluded.
  • Recruitment Strategies
  • Patients that are seen in clinic at MD Anderson, Memorial Sloan Kettering Cancer Center and Mount Sinai meeting eligibility criteria will be screened for the protocol
  • Other participant sources will be from outside physician referrals.
  • Our outside physician referral network has a high representation of minorities.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Mount Sinai Hospital

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Trial of Isatuximab (SAR650984) With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)

This is a multi-center, open label, phase II study designed to evaluate the efficacy of isatuximab with or without lenalidomide when given to patients with high risk smoldering multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVE:

  • To determine the rate of response according to the International Myeloma Working Group Criteria.

SECONDARY OBJECTIVES:

  • To determine progression free survival (PFS) at 2 years.
  • To determine overall survival (OS).
  • To determine duration of response (DOR).
  • To determine the clinical benefit rate (CBR).
  • To evaluate safety of single agent treatment in this population
  • To evaluate safety of single agent treatment in this population.
  • To evaluate the immunogenicity of isatuximab.

OUTLINE:

Patients on single agent cohort receive isatuximab intravenously (IV) over 5 hours on day 1 of cycle 1, and over 3 hours thereafter on days 8, 15, and 22 of cycle 1, on days 1 and 15 of cycles 2-6, and on day 1 of subsequent cycles.

Patients on Combination Cohort with Lenalidomide receive isatuximab as in single agent cohort plus Lenalidomide po 21/28 days during cycles 1-6 only. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity.

Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6-12 months.

Being tested
Isatuximab, Laboratory Biomarker Analysis
Medical subject headings
Smoldering Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsatuximabBiological

    Also called Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR650984

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02960555
Study groupRoleWhat they receive
Treatment (isatuximab)ExperimentalPatients receive isatuximab IV over 5 hours on day 1 of cycle 1, and over 3 hours thereafter on days 8, 15, and 22 of cycle 1, on days 1 and 15 of cycles 2-6, and on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Isatuximab; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response (>= partial response)

    The trial will be conducted by the Simon's optimal two-stage design and the response rate will be estimated accordingly. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate and the adverse event rate.

    Measured: 6 months

Secondary outcomes (3)

  1. Progression free survival

    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: 2 years

  2. Overall survival

    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.

    Measured: Up to 5 years

  3. Incidence of adverse events

    Adverse events will be summarized by frequency tables for all patients. For the safety endpoint, per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2016 (estimated)
  2. Study start8 Feb 2017
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

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
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960555
Sponsor's protocol ID
2015-0148
Other IDs
NCI-2016-01922, 2015-0148
Status last verified
Oct 2026
First submitted
8 Nov 2016
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isatuximab and Laboratory Biomarker Analysis in people with Smoldering Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 3 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 16 inclusion and 27 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Overall response (>= partial response) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02960555.

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 6 Oct 2026.

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