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Multiple MyelomaPhase 2VICDNCT04240054

Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency

A Phase 2 study testing Bortezomib, Isatuximab and Cyclophosphamide in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, open-label phase II study with a safety lead-in phase. 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?
Bortezomib, Isatuximab and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
2 Nov 2021to 1 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

  • Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Male or female subjects ≥18 years.
  • Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines.
  • No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m^2) and/or cyclophosphamide up to 500 mg/m^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than four weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment (at least one of the following: Serum protein electrophoresis (SPEP)/Immunofixation electrophoresis (IFE), 24-hour urine protein with urine protein electrophoresis (UPEP)/ IFE, serum free light chains and bone marrow procedure) must be available.
  • Patients must have documented multiple myeloma as defined by the criteria below (a, b, and c):
  • Monoclonal plasma cells in the bone marrow of ≥10% or presence of a biopsy proven plasmacytoma AND
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  • Evidence of organ damage or myeloma-defining events (MDE) that can be attributed to the underlying proliferative plasma cell disorder (at least one of the following):
  • Hypercalcemia: corrected serum calcium >1 mg/dL higher than the upper limit of normal (ULN) or >11 mg/Dl.
  • OR
  • Anemia: hemoglobin value of >2.0 g/dL below the lower limit of normal, or a hemoglobin value <10.0 g/dL.
  • OR
  • Bone marrow plasma cells of >60%. OR
  • Involved/uninvolved light chain ratio ≥100 OR
  • Renal insufficiency: eGFR < 40 mL/min/1.73m^2 (based on the Modification of Diet in Renal Disease MDRD formula). [Cohort A subjects must meet this criterion.] If the patient is enrolled in the renal impaired (RI) A cohort but Cycle 1 Day 1 labs do not meet RI definition, the patient will be considered RI (reconsent and rescreening are not required).
  • Measurable disease as defined (at least one of the following):
  • Serum M-protein level ≥0.5 g/dL; OR
  • Urine M-protein level ≥200 mg/24 hours; OR
  • Light chain multiple myeloma without measurable disease in the urine: serum immunoglobulin (Ig) free light chains (FLC) ≥10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Female subjects who:
  • Are postmenopausal for at least one year before the screening visit, OR
  • Are surgically sterile, OR
  • Females of childbearing potential or male subjects with female partners of childbearing potential shall be required to use effective contraceptive methods (double barrier method, intrauterine device, oral contraception or abstinence) starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s). A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. The following highly effective methods of contraception are accepted:
  • Established use of oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation.
  • Established use of oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
  • Placement of an intrauterine device or intrauterine hormone-releasing system.
  • Barrier methods of contraception: male condom with either cap, diaphragm or sponge with spermicide (double-barrier methods). The use of double-barrier methods should always be supplemented with the use of a spermicide. Female condom and male condom should not be used together.
  • Male sterilization (provided that the partner is the sole sexual partner of the patient and that the sterilized partner has received medical assessment of the surgical success).
  • Sexual abstinence.
  • Female subjects must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
  • Male subjects, even if surgically sterilized (i.e., status postvasectomy), who:
  • Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through four months after the last dose of study drug(s) (female and male condoms should not be used together), or
  • Agree to practice true abstinence during the entire study treatment period from the time of signing the informed consent through 16 weeks after the last dose of study drug(s), when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)

Who cannot join

  • For renal impaired Cohort A subjects, any subject who requires immediate treatment for management of renal failure (including, but not limited to, dialysis). Such treatment is allowed once the patient becomes stable, based on investigator's discretion.
  • Diagnosed or treated for malignancy other than multiple myeloma, except:
  • Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment or documentation that the malignancy required/requires no treatment at time of enrollment.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ (e.g., cervical, breast) with no evidence of disease.
  • Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
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  • Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have untreated or active hepatitis C.
  • Concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study. Specifically, any potential subject who is unsuitable for ASCT would be excluded from the study.
  • Clinically significant cardiac disease, including:
  • Myocardial infarction within six months before Cycle 1, Day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV).
  • Uncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities.
  • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec.
  • Uncontrolled hypertension.
  • Any of the following laboratory test results at the time of enrollment:
  • Absolute neutrophil count <1.0 × 109/L; no granulocyte colony stimulating factor (G-CSF) treatment in the past seven days are allowed.
  • Hemoglobin level ≤7.5 g/dL (≤5 mmol/L); blood transfusions to maintain hemoglobin >7.5 g/dL are acceptable.
  • Platelet count <75 × 109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count <50 × 109/L; no platelet transfusions in the past seven days are allowed.
  • Alanine aminotransferase (ALT) level ≥2.5 × ULN
  • Aspartate aminotransferase (AST) level ≥2.5 × ULN
  • Total bilirubin level ≥1.5 × ULN, (except for Gilbert Syndrome: direct bilirubin ≥2 × ULN)
  • Known allergies, hypersensitivity (if not amenable to premedication with steroids, or H2 blockers), or intolerance to monoclonal antibodies or human proteins, isatuximab or its excipients or known sensitivity to mammalian-derived products.
  • Plasma cell leukemia (>2.0 × 10^9/L circulating plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and/or skin changes), or light-chain amyloidosis.
  • Known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder) or the subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
  • Pregnant or breastfeeding or planning to become pregnant starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
  • Plans to father a child starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
  • Had major surgery within two weeks before Cycle 1, Day 1, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within two weeks after the last dose of study drug administration. Note: Subjects with planned surgical procedures to be conducted under local anesthesia are not excluded. Kyphoplasty is not considered a major surgery.
  • Patients with pre-existing uncontrolled pulmonary 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 six months prior to enrollment in the study; patients with previous history of pneumonitis will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States1 site, 1 recruiting

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Medical College of Wisconsin Cancer Center Clinical Trials Office, 866-680-0505 ext. 8900, cccto@mcw.edu

    Binod Dhakal, MD

    Recruiting

Other trials in United States

About this study

Official title: A Multisite, Phase II Study of Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone (VICD) Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency

This is a single-arm, open-label phase II study with a safety lead-in phase.

Read the detailed description

The study hypothesis is that the isatuximab plus bortezomib, cyclophosphamide and dexamethasone (VCD) combination is safe and highly effective even in those with renal insufficiency (RI) from myeloma. In this study, we seek to improve the efficacy of VCD by adding isatuximab in newly diagnosed multiple myeloma patients undergoing autologous stem cell transplant (ASCT) irrespective of renal function.

The primary objective is to determine if the addition of isatuximab to VCD will increase the proportion of subjects achieving very good partial response (VGPR), as defined by the International Myeloma Working Group (IMWG) criteria and by the time of completion of post-ASCT consolidation treatment.

Being tested
Bortezomib, Isatuximab, Cyclophosphamide, Dexamethasone
Keywords
Multiple Myeloma, Renal Insufficiency, Isatuximab
Medical subject headings
Multiple Myeloma, Renal Insufficiency

What participants receive

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

  • BortezomibDrug

    Also called Velcade

    Bortezomib (1.5 mg/m^2) subcutaneous on days 1, 8 and 15

  • IsatuximabDrug

    Also called SAR650984

    Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar, cytophosphane

    Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15

  • DexamethasoneDrug

    Also called Baycadron, Decadron, DexPak, TaperDex

    Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23

Study groups in NCT04240054
Study groupRoleWhat they receive
Safety Lead-in Cohort AExperimentalSix transplant-eligible multiple myeloma patients with renal impairment will be enrolled. Bortezomib (1.5 mg/m^2) subcutaneous on days 1,8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9,15,16, 22 and 23
Receives: Drug: Bortezomib; Drug: Isatuximab; Drug: Cyclophosphamide; Drug: Dexamethasone
Expansion Cohort AExperimental35 transplant-eligible multiple myeloma patients with renal impairment will be enrolled. Bortezomib (1.5 mg/m^2)subcutaneous on days 1, 8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9,15,16, 22 and 23
Receives: Drug: Bortezomib; Drug: Isatuximab; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

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

  1. The number of subjects who achieve very good partial response.

    This will be measured using the International Myeloma Working Group criteria.

    Measured: 100 days following autologous stem cell transplant

Secondary outcomes (2)

  1. The number of subjects who achieve complete response.

    This will be measured using the International Myeloma Working Group criteria.

    Measured: 100 days following autologous stem cell transplant.

  2. The number of subjects who achieve partial response.

    This will be measured using the International Myeloma Working Group criteria.

    Measured: 100 days following autologous stem cell transplant.

Timeline

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

  1. First posted27 Jan 2020
  2. Study start2 Nov 2021
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04240054
Sponsor's protocol ID
PRO00036788
Acronym
VICD
Status last verified
Jan 2026
First submitted
22 Jan 2020
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib, Isatuximab and Cyclophosphamide in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site 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 33 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of subjects who achieve very good partial response. (time frame: 100 days following autologous stem cell transplant). 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 NCT04240054.

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 Jan 2026.

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