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A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse." (I2D IFM2021_03)

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ClinicalTrials.gov Identifier: NCT04998786
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse .

The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.


Condition or disease Intervention/treatment Phase
Multiple Myeloma at First Relapse Drug: Ixazomib Drug: Iberdomide Drug: Dexamethasone Oral Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."
Actual Study Start Date : December 14, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2027


Arm Intervention/treatment
Experimental: assessment of treatment Ixazomib, dexamethasone, iberdomide
Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression
Drug: Ixazomib
Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress

Drug: Iberdomide
Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress

Drug: Dexamethasone Oral
Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22




Primary Outcome Measures :
  1. Percentage of patients have very good partial response (VGPR) or better [ Time Frame: approximate 18 months ]
    Using IMWG criteria


Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: approximate 18 months ]
    Number of adverse events defined by Common Terminology Criteria for Adverse Events (v5)

  2. Number of responses [ Time Frame: 3 months ]
    Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG

  3. Number of responses [ Time Frame: 6 months ]
    Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG

  4. Number of the death [ Time Frame: approximate 18 months ]
    is defined as the time in months from inclusion to the date of death due to any cause. Subject alive will be censored at the last known alive date.

  5. Number of progression [ Time Frame: approximate 18 months ]
    is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria

  6. Percentage of time to progression [ Time Frame: approximative 18 months ]
    is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria

  7. Percentage of duration of response [ Time Frame: approximative 18 months ]
    is defined as the time from the first response (PR or better) to the date of disease progression or death due to any cause

  8. Percentage of duration of therapy [ Time Frame: approximative 18 months ]
    is defined as the time from treatment initiation to the last dose of therapy

  9. Percentage of time to response [ Time Frame: approximative 18 months ]
    according IMWG

  10. Percentage of Overall Response Rate [ Time Frame: approximative 18 months ]
    according IMWG

  11. Percentage of value of biological prognostic factors [ Time Frame: day 1 ]
    prognostic factors as ISS stage, cytogenetic as del(17p), t(4;14),

  12. Percentage of frailty scores [ Time Frame: day 1 ]
    age, ECOG, comorbidity index

  13. Percentage of score of quality of life [ Time Frame: approximative 18 months ]
    To assess Quality of Life EQ5D and SF36



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 70 years
  2. Eastern Collaborative Oncology Group (ECOG) performance score of ≤2
  3. Life expectancy > 6 months
  4. Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
  5. Symptomatic multiple myeloma (MM) at first relapse, as defined below:

    • Symptomatic multiple myeloma according to international criteria.(Rajkumar et al, 2014)
    • Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy.
  6. Subject must have received one prior line of therapy for at least 3 cycles.
  7. Subject has measurable disease at Screening, defined at least one of the following:

    • Serum M-protein ≥ 0.5 gram (g)/deciliter (dL), OR
    • Urine M-protein ≥ 200 mg in 24 hours, OR
    • Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal.
  8. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1):

    • Absolute neutrophil count (ANC) ≥ 1000/microliter (μL). Subjects may use growth factor support to achieve ANC eligibility criteria.
    • Platelet count ≥ 75,000 /mm3 for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count ≥ 50,000/mm3 for subjects in whom > 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts within 3 days before study.

      --AST and ALT ≤ 3 × upper limit of normal (ULN).

    • Total bilirubin ≤ 1.5 × ULN. Subjects with documented Gilbert's syndrome may have bilirubin > 1.5 × ULN with the approval of the Primary Therapeutic Area Medical Director
    • Creatinine clearance (CrCl) ≥ 30 milliliter (mL)/minute (min) (using Cockroft and Gault Formula)
  9. Patient should comply with Celgene's pregnancy prevention plan for Iberdomide (please see appendix 8 Iberdomide Pregnancy Prevention Plan for subjects in clinical trials)
  10. Female patients who:

    • are postmenopausal for at least 24 months before the screnning visit, OR
    • are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy)
  11. Men even if surgically sterilized must agree to not father a child and agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential or pregnant.

Non-inclusion Criteria:

  1. Subject is refractory to bortezomib, defined as progression on or within 60 days of the last dose of bortezomib.
  2. Subject has had prior treatment with ixazomib, carfilzomib, pomalidomide or iberdomide
  3. Subject has any of the following conditions:

    • Non-secretory or oligo-secretory MM
    • Light chain Amyloidosis (AL Amyloidosis)
    • POEMS syndrome Waldenström macroglobulinemia
  4. Known Human Immunodeficiency Viral (HIV) infection
  5. Active hepatitis B or C infection based on blood screen tests
  6. Significant cardiovascular or pericardial disease, including uncontrolled angina, hypertension, arrhythmia, recent myocardial infarction within 6 months, congestive, heart failure New York Heart Association (NYHA) Class ≥ 3
  7. Major surgery within 4 weeks prior screening
  8. Acute infections requiring parenteral therapy (antibiotic, antifungal or antiviral) within 14 days
  9. ≥ Grade 3 Peripheral neuropathy or grade 2 with pain
  10. Uncontrolled diabetes or uncontrolled hypertension within 14 days
  11. Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study
  12. Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions:

    • Adequately treated in situ carcinoma of the cervix uteri or the breast,
    • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin,
    • Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment,
    • Previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
  13. Known intolerance to steroid therapy
  14. Serious medical or psychiatric illness likely to interfere with participation in study
  15. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs
  16. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
  17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04998786


Contacts
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Contact: Touzeau 02.40.08.32.71 cyrille.touzeau@chu-nantes.fr

Locations
Show Show 21 study locations
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Cyrille Touzeau CHU de Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04998786    
Other Study ID Numbers: RC21_0169
2021-001587-13 ( EudraCT Number )
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Multiple Myeloma, elderly patients, first relapse, previous exposed, High Risk, Ixazomib, Iberdomide, Dexametasone
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Recurrence
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Dexamethasone
Ixazomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents