Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NL-OMON54962
NL-OMON54962RecruitingPhase 3

PHASE III STUDY OF ISATUXIMAB-CARFILZOMIB-LENALIDOMIDE-DEXAMETHASONE (Isa-KRd) VERSUS CARFILZOMIB-LENALIDOMIDE-DEXAMETHASONE (KRd) IN NEWLY DIAGNOSED MYELOMA PATIENTS ELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION (IsKia TRIAL) - EMN24/HOVON 503 MM

Stichting European Myelooma Network - EMN, contact pers P. Sonneveld0 sites70 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
70
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Patient with newly diagnosed multiple myeloma and eligible to ASCT, for whom
  • •the standard treatment it is not, according to investigator, the best treatment
  • •2. Patient is, in the investigator*s opinion, willing and able to comply with
  • •the study visits and procedures required per protocol.
  • •3. Patient has provided written informed consent. Subject does not have kind of
  • •condition that, in the opinion of the Investigator, may compromise the ability
  • •of the subject to give written informed consent and patient is, in the
  • •investigator(s) opinion, willing and able to comply with the protocol
  • •requirements.
  • •4. Monoclonal plasma cells in the bone marrow >=10% or presence of a biopsy
  • •proven plasmacytoma and documented multiple myeloma satisfying at least one of
  • •the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy
  • •CRAB criteria:
  • •- Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than upper limit
  • •of normal (ULN) or >2.75 mmol/L (>11 mg/dL)
  • •- Renal insufficiency: creatinine clearance <40mL/min or serum creatinine >177
  • •µmol/L (>2 mg/dL)
  • •- Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10
  • •- Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or
  • •Biomarkers of Malignancy:
  • •- Clonal bone marrow plasma cell percentage >=60%
  • •- Involved: uninvolved serum FLC ratio >=100
  • •- >1 focal lesion on magnetic resonance imaging (MRI) studies
  • •5. Patient is 18 - 70 years old and is eligible for autologous stem cell
  • •transplantation
  • •6. Patient has measurable disease as defined by any one of the following:
  • •- Serum monoclonal paraprotein (M-protein) level >=1.0 g/dL or urine M-protein
  • •level >=200 mg/24 hours; or
  • •- Light chain multiple myeloma without measurable disease in the serum or the
  • •urine: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin
  • •kappa lambda FLC ratio.
  • •7. Life expectancy >= 3 months
  • •8. ECOG status <=2
  • •9. Clinical laboratory values meeting the following criteria during the
  • •Screening Phase:
  • •o Adequate hepatic function, with serum ALT <= 2.5 times ULN, AST <= 2.5 x the
  • •o Serum direct bilirubin <= 1.5 ULN (except in subjects with congenital
  • •bilirubinemia, such as Gilbert syndrome, direct bilirubinemia <= 1.5 ULN)
  • •o Absolute neutrophil count (ANC) >= 1.0 × 109/L
  • •o Platelet count >= 75× 109/L (>= 50× 109/L if myeloma involvement in the bone
  • •marrow is > 50%) and no platelet infusion in the 1 week prior to screening
  • •platelet count
  • •o Creatinine clearance (CrCl) >= 30 mL/minute. Creatinine clearance should be
  • •calculated using eGFR (Modified Diet in Renal Disese [MDRD])
  • •o Corrected serum calcium <= 13.5 mg/dL (3.4 mmol/L)
  • •o LVEF >= 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method
  • •of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not
  • •10. Females of childbearing potential (FCBP)* complies with the conditions of
  • •the Pregnancy Prevention Plan, including confirmation that she has an adequate
  • •level of understanding and must agree to ongoing pregnancy testing and to
  • +3 more not shown

Exclusion Criteria

  • •1. Previous treatment with anti-myeloma therapy (does not include radiotherapy,
  • •biphosphonates, or a single short course of steroid <= to the equivalent of
  • •dexamethasone 40 mg/day for 4 days).
  • •2. Patients with non-secretory MM unless serum free light chains are present
  • •and the ratio is abnormal or a plasmacytoma with minimum largest diameters of >
  • •3. Patients with plasma cell leukemia, amyloidosis, Waldenstrom Disease, POEMS
  • •4. Meningeal involvement of multiple myeloma
  • •5. Patient ineligible for autologous transplantation
  • •6. Pregnant or lactating females
  • •7. Acute active infection requiring treatment (systemic antibiotics,
  • •antivirals, or antifungals) within 14 days prior to randomization
  • •8. Known human immunodeficiency virus infection (HIV)
  • •9. Active hepatitis A, B or C infection. Hepatitis C infection (subjects with
  • •hepatitis C that achieve a sustained virologic response after antiviral therapy
  • •are allowed), or hepatitis B infection (subjects with hepatitis B surface
  • •antigen or core antibody that achieve sustained virologic response with
  • •antiviral therapy are allowed). Tests to be performed if required per local
  • •country regulations (in Czech Republic
  • •testing for HIV and hepatitis B and C is required at screening). In fact it is
  • •not possible to avoid the risk of virological reactivation with the study
  • •treatments.
  • •Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV
  • •- Patient can be eligible if anti-HBc IgG positive (with or without positive
  • •anti-HBs) but HBsAg
  • •and HBV DNA are negative. If anti-HBV therapy in relation with prior infection
  • •was started
  • •before initiation of IMP, the anti-HBV therapy and monitoring should continue
  • •throughout the
  • •study treatment period.
  • •- Patients with negative HBsAg and positive HBV DNA observed during screening
  • •period will
  • •be evaluated by a specialist for start of anti-viral treatment: study treatment
  • •could be proposed
  • •if HBV DNA becomes negative and all the other study criteria are still met.
  • •Active HCV infection: positive HCV RNA and negative anti-HCV
  • •- Patients with antiviral therapy for HCV started before initiation of IMP and
  • •positive HCV
  • •antibodies are eligible. The antiviral therapy for HCV should continue
  • •throughout the treatment
  • •period until seroconversion.
  • •- Patients with positive anti-HCV and undetectable HCV RNA without antiviral
  • •therapy for HCV
  • •are eligible.
  • •10. Unstable angina or myocardial infarction within 4 months prior to
  • •randomization, NYHA Class III or IV heart failure, uncontrolled angina,
  • •uncontrolled hypertension, (Uncontrolled hypertension, defined as an average
  • •systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg despite optimal
  • •treatment, in the last 5 years pulmonary embolia, history of severe coronary
  • •artery disease, severe uncontrolled ventricular arrhythmias, sick sinus
  • •syndrome, or electrocardiographic evidence of acute ischemia or Grade 3
  • +6 more not shown

Investigators

Sponsor
Stichting European Myelooma Network - EMN, contact pers P. Sonneveld

Similar Trials

Active, not recruiting
Phase 1
A Clinical trial to compare the combination of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone versus the combination of Carfilzomib-Lenalidomide-Dexamethasone in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)newly diagnosed multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2019-004844-32-CZStichting European Myeloma Network – EM300
Active, not recruiting
Phase 1
A Clinical trial to compare the combination of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone versus the combination of Carfilzomib-Lenalidomide-Dexamethasone in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)ewly diagnosed multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
EUCTR2019-004844-32-ITSTICHTING EUROPEAN MYELOMA NETWORK300
Recruiting
Phase 3
A Clinical trial to compare the combination of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone versus the combination of Carfilzomib-Lenalidomide-Dexamethasone in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)
2024-513422-38-00European Myeloma Network Stichting, Emn Trial Office S.r.l. Impresa Sociale302
Active, not recruiting
Phase 1
A Clinical trial to compare the combination of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone versus the combination of Carfilzomib-Lenalidomide-Dexamethasone in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)newly diagnosed multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2019-004844-32-NLStichting European Myeloma Network - EM300
Active, not recruiting
Phase 1
A Clinical trial to compare the combination of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone versus the combination of Carfilzomib-Lenalidomide-Dexamethasone in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (IsKia TRIAL)
EUCTR2019-004844-32-GREuropean Myeloma Network – EM300