Status:
ACTIVE_NOT_RECRUITING
A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant
Lead Sponsor:
Fondazione EMN Italy Onlus
Conditions:
Multiple Myeloma
New Diagnosis Tumor
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The combination of lenalidomide plus low-dose dexamethasone (Rd) is considered the new standard for elderly newly diagnosed multiple myeloma (NDMM) patients. The combination carfilzomib plus lenalidom...
Detailed Description
This protocol is a randomized, multicenter study designed to determine the MRD negativity and the PFS of KRd treatment regimen. Patients will be randomized in a 1:1 ratio to receive carfilzomib-lenal...
Eligibility Criteria
Inclusion
- Newly diagnosed symptomatic MM based on either standard CRAB criteria (at least 10% of clonal bone marrow plasma cells plus CRAB defined as the onset of any of the following clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) or at least 10% of bone marrow plasma cells plus the presence of at least one of the following biomarkers of malignancy:
- 60% or greater clonal plasma cells on bone marrow examination;
- Serum involved/uninvolved free light chain (FLC) ratio of 100 or greater;
- More than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size.
- Patient not eligible for ASCT (age ≥ 65 years or abnormal cardiac, pulmonary and liver function).
- Patient defined as fit or intermediate according to the IMWG (International Myeloma Working Group) frailty score
- Patient has given voluntary written informed consent.
- Patient is able to be compliant with hospital visits and procedures required per protocol.
- Patient agrees to use acceptable methods for contraception.
- Patient has measurable disease according to IMWG criteria.
- Patient has ECOG (Eastern Cooperative Oncology Group) performance status \< 3.
- Pre-treatment clinical laboratory values within 30 days before randomization:
- Platelet count ≥50 x 109/L (≥30 x 109 /L if myeloma involvement in the bone marrow is \> 50%)
- Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors
- Corrected serum calcium ≤14 mg/dL (3.5 mmol/L)
- Alanine transaminase (ALT): ≤ 3 x the ULN
- Total bilirubin: ≤ 2 x the ULN
- Calculated or measured creatinine clearance: ≥ 30 mL/minute.
- LVEF≥ 40%: 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation; multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available
- Pre-treatment blood pressure value \< 140/90 mmHg even with adequate therapy: 24 hours blood pressure monitoring is the preferred method of evaluation; blood pressure diary at home for 2 weeks is acceptable.
- Females of childbearing potential (FBCP) comply with the conditions of the Pregnancy Prevention Plan, including confirmation that she has an adequate level of understanding.
- FBCP must follow the Pregnancy Prevention Plan and use a highly effective and an additional barrier contraception method simultaneously for 4 weeks before starting therapy, during treatment and dose interruptions and for at least 30 days after the last dose of study drugs\*
- Males must use an effective barrier method of contraception if sexually active with FCBP during the treatment and for at least 90 days after the last administration of study drug/s. Male subjects must agree to refrain from sperm donation for at least 90 days after the last dose of carfilzomib.
Exclusion
- Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the screening or place the subject at unacceptable risk.
- Patient defined as frail according to the IMWG frailty score.
- Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \< to the equivalent of dexamethasone 40 mg/day for 4 days).
- Pregnant or lactating females.
- Presence of:
- Clinical active infectious hepatitis type A, B, C or HIV
- Acute active infection requiring antibiotics or infiltrative pulmonary disease
- Pulmonary hypertension and interstitial lung disease
- Uncontrolled arrhythmias or history of QT prolongation
- Myocardial infarction or unstable angina ≤ 6 months or other clinically significant heart disease
- Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 5.0 (Appendix A)
- Uncontrolled hypertension defined as persistent hypertension (\>140/90 mmHg) regardless treatment with 3 drugs, including a diuretic.
- Contraindication to any of the required drugs or supportive treatments and hypersensitivity to any excipient of the study drugs.
- Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib).
- Invasive malignancy within the past 3 years.
- Administration of any experimental drug within 4 weeks prior the baseline or within 5 drug half-lives.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04096066
Start Date
July 1 2019
End Date
January 1 2026
Last Update
January 15 2025
Active Locations (40)
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1
AO "SS. Antonio e Biagio"
Alessandria, Italy
2
AOU Ospedali Riuniti Umberto I
Ancona, Italy
3
Ospedale Mazzoni
Ascoli Piceno, Italy
4
Policlinico di Bari
Bari, Italy