Isatuximab Lenalidomide Bortezomib and Dexamethasone in NDMM

  • STATUS
    Recruiting
  • End date
    Mar 13, 2024
  • participants needed
    43
  • sponsor
    Jacob Laubach
Updated on 1 August 2021
platelet count
measurable disease
dexamethasone
lenalidomide
neutrophil count
bortezomib

Summary

This research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.

Description

This is a multi-center, single-arm, open-label, Phase 2 study in patients with newly diagnosed multiple myeloma (NDMM) eligible for high dose therapy (HDT) and autologous stem cell transplant (ASCT).

In this research study, investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide, bortezomib, and dexamethsone.

  • This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide, bortezomib, and dexamethasone.
  • This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasn't been approved.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Newly Diagnosed Multiple Myeloma, multiple myeloma (mm), Autologous Stem Cell Transplant
Treatment Dexamethasone, Lenalidomide, Isatuximab, bortezomib injection
Clinical Study IdentifierNCT04653246
SponsorJacob Laubach
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment
Provided voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Age 75 years, with patients over the age of 70 requiring PI approval
Measurable disease defined as at least one of the following
Serum M protein 0.5 g/dL (5 g/L)
Urine M protein 200 mg/24 hours
Serum free light chain (FLC) assay: Involved FLC assay 10 mg/dL (100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
Screening Laboratory evaluations within the following parameters
Absolute neutrophil count (ANC) 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used within 14 days before first drug administration)
Platelet count 75,000 cells/dL (75 x 109/L) if < 50% BM nucleated cells are plasma cells, 30,000 cells/dL if 50% of BM nucleated cells are plasma cells. (without transfusions required during the 3 days prior to the screening hematologic test)
Total Bilirubin 2.0 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
AST (SGOT) and ALT (SGPT) 3.0 x ULN
Calculated creatinine clearance 30 mL/min
Hemoglobin 8 g/dL
ECOG performance status 2 (Appendix A)
Participant agrees to be registered into the mandatory Revassist REMS program, and be willing and able to comply with the requirements of the RevAssist REMS program
Ability to understand and the willingness to sign a written informed consent document
Participant is considered eligible for ASCT by the treating physician

Exclusion Criteria

Prior therapy for multiple myeloma
Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
Central nervous system involvement
Peripheral neuropathy Grade 3, or Grade 2 with pain on clinical examination during the screening period
Any medical or psychiatric illness that in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study
Concurrent uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, Grade 3 thromboembolic event or myocardial infarction within the past 6 months
Prior major surgical procedure or radiation therapy within 4 weeks of initiation of therapy (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy)
Daily requirement for corticosteroids (equivalent to > 10 mg/day prednisone for more than 7 days (except for inhalation corticosteroids)
Concurrent symptomatic amyloidosis or plasma cell leukemia
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
Known active infection requiring parenteral or oral anti-infective treatment within 14 days of start of therapy
Active hepatitis B or hepatitis C viral infection
Pregnant or breastfeeding female or female who intends to become pregnant during the participation in the study. Females of childbearing potential (FCBP) unwilling to prevent pregnancy by the use of 2 reliable methods of contraception for 4 weeks before the start of study treatment, during treatment (including dose interruptions), and up to 3 months following the last dose of study treatment and/or who are unwilling or unable to be tested for pregnancy before study treatment initiation (2 negative tests), weekly during 1st month of treatment and then prior each treatment cycle administration or every 2 weeks in case or irregular menstrual cycles up to 3 months following the last dose of study treatment
Male participants who disagree to practice true abstinence or disagree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and at least 3 months following study treatment discontinuation, even if has undergone a successful vasectomy
Note 1: a FCBP is a female who: 1) has achieved menarche at some time point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)
Note 2: True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Receiving any other investigational agents
Inability to tolerate thromboprophylaxis
Hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80, or to any of the components of the study therapy
Hypersensitivity to steroids or H2 blockers that would prohibit further treatment with these agents
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