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Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma (ERASMM)

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ClinicalTrials.gov Identifier: NCT06183489
Recruitment Status : Recruiting
First Posted : December 27, 2023
Last Update Posted : May 16, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Stichting European Myeloma Network

Study Description
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Brief Summary:
This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Condition or disease Intervention/treatment Phase
Smoldering Multiple Myeloma Drug: Elranatamab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
Actual Study Start Date : May 14, 2024
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Elranatamab
Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)
 Drug: Elranatamab
Elranatamab will be administered via a subcutaneous injection (SC)


Outcome Measures
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Primary Outcome Measures :
  1. Complete Remission (CR) rate [ Time Frame: average 24 weeks ]
    Response of CR is defined as participants who achieve a CR or better (CR+sCR) according to IMWG response criteria, during the first 6 cycles of treatment and before a possible early termination of the treatment


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: average 24 weeks ]
    Overall response rate (ORR) is defined as the proportion of participants achieving a confirmed PR or better according to the IMWG response criteria.

  2. MRD-negative CR (MRD_CR) [ Time Frame: average 24 weeks ]
    MRD-negative CR (MRD_CR) is defined as the proportion of participants achieving a MRD negativity (at or below the threshold of 10-5 by NGS) and CR or better according to the IMWG response criteria.

  3. Progression-free survival (PFS) [ Time Frame: time from the date of 1st dose to to the date of disease progression or death, assed up to 4 years after last dose ]
    defined as the time from the date of 1st dose of study drug to the date of first confirmed PD, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first. If the participant is alive and w/o progression disease, the participant's data will be censored at the date of last disease assessment.

  4. Time to progression (TTP) [ Time Frame: time from the date of 1st dose to progression or death, assed up to 4 years after last dose ]
    Time to progression (TTP) is defined as the time from the date of 1st dose of study drug to the date of first documented PD, as defined in the IMWG response criteria. If the participant is w/o progression disease or die, the participant's data will be censored at the date of last disease assessment.

  5. Progression free survival 2 (PFS2) [ Time Frame: time from the date of 1st dose to progression on the next line of treatment or death,assed up to 4 years after last dose ]
    Progression free survival 2 (PFS2) is defined as the time from the date of 1st dose of study drug to the date of event, which is defined as death from any cause or PD as assessed by investigator that starts after the next line of therapy, whichever occurs first. If the participant starts next line of subsequent therapy without disease progression on study treatment, participant's data will be censored at the last disease assessment before starting next line of therapy. If participant starts next line of therapy after progression on study treatment and is still alive and not yet progress on next line of therapy, participant's data will be censored on the last date of follow-up.

  6. Overall survival (OS) [ Time Frame: time from the date of 1st dose to date of death, assed up to 4 years after last dose ]
    Overall survival (OS) is defined as the time from the date of 1st dose of study drug to the date of death. If the participant is alive, the participant's data will be censored at the date the participant was last known to be alive

  7. Time to response (TTR) [ Time Frame: time frrom the date of 1st dose to the first documented response ]
    Time to response (TTR) is defined as the time from the date of 1st dose of study drug to the first documented response (≥PR). If the participant is alive, w/o progression disease and w/o documented response (≥PR), the participant's data will be censored at the date of last disease assessment. If the participant have a progression or die before a documented response (≥PR), the participant's data will have a competing event at the date of PFS event.

  8. Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) [ Time Frame: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment ]
    The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-ofLife (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.

  9. Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score [ Time Frame: from screening, cycle 1 and every 3 cycles there after up to end of treatment and 28 days after last treatment ]
    The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in subjects with MY. The module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment,Future Perspective, and Body Image. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >18 years of age

  2. Diagnosis of SMM for ≤5 years with measurable disease, defined as serum M protein:

    ≥1g/dL or urine M protein ≥200 mg/24 hours or involved serum FLC ≥100 mg/Land abnormal serum FLC ratio.

  3. BMPCs ≥10% and <60%

  4. Presence of at least 2 high risk factors, including

    1. Serum M protein ≥2 g/dL,
    2. BMPC >20%
    3. Serum involved/uninvolved FLC ratio > 20
  5. ECOG performance status score of 0 or 1

  6. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1)

    1. Absolute neutrophil count ≥1.0 x 109/L (ie, ≥1000/μL)
    2. Platelet count ≥75 x 109/L
    3. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)
    4. Alanine aminotransferase (ALT) ≤2.5 x ULN
    5. Total bilirubin ≤1.5 x ULN, except in subjects with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤2.0 x ULN is required)
  7. Subject must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study.
  8. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (One highly effective method and one additional effective method) used at the same time, and continuing for at least 5 months after the last dose of Elranatamab. Women must also agree to notify pregnancy during the study.

Exclusion Criteria:

  1. Previous therapy with any systemic therapy for multiple myeloma.

  2. Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement):

    1. Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL
    2. Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL
    3. Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted
    4. ≥ 1 bone lytic lesion
    5. BMPCs ≥60%
    6. Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L
    7. Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter)
  3. Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma.
  4. Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
  5. Subject has had plasmapheresis within 14 days of elegibility confirmation.
  6. Myocardial infarction within 6 months prior to enrolment according to NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  7. Ongoing Grade 2 or higher peripheral sensory/motor peripheral neuropathy (PN), history of GBS or GBS variants, or history of grade 3 or higher peripheral motor polyneuropathy
  8. Subject has had major surgery within 2 weeks before elegibility confirmation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study.
  9. Clinically relevant active infection or serious co-morbid medical conditions
  10. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer free of disease since 5 years.
  11. Female subject who is pregnant or breast-feeding
  12. Serious medical or psychiatric illness likely to interfere with participation in study
  13. Uncontrolled diabetes mellitus
  14. Known HIV infection; Known active hepatitis B or C viral infection; known active COVID-19/SARS-CoV-2 infection
  15. Live attenuated vaccine administered within 4 weeks of the first dose of study intervention
  16. Ongoing treatment with corticosteroids : dose >10mg prednisone etc.
  17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
Contacts and Locations
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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): NCT06183489


Contacts
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Contact: Silvia Villa +31 107033123 silvia.villa@emn.org

Locations
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Sponsors and Collaborators
Stichting European Myeloma Network
Pfizer
More Information
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Responsible Party: Stichting European Myeloma Network
ClinicalTrials.gov Identifier: NCT06183489    
Other Study ID Numbers: EMN34/2023-505775-70-00
First Posted: December 27, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Stichting European Myeloma Network:
high-risk smoldering Multiple Myeloma
Elranatamab
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
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
Precancerous Conditions
Hypergammaglobulinemia