This protocol is a phase II randomized, multicenter study designed to assess the safety and the efficacy of different carfilzomib combinations in newly diagnosed MM patients eligible for autologous transplantation (ASCT).

A MULTICENTER, RANDOMIZED, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (CCyd) as pre transplant INDUCTION and post transplant consolidation or CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (CRd) as pre transplant INDUCTION and post transplant consolidation or continuous treatment with CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE (12 cycles) without transplant, all followed by MAINTENANCE with LENALIDOMIDE (R) versus LENALIDOMIDE AND CARFILZOMIB (CR) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000782-53-IT

Enrollment

477

Registered

2014-10-03

Start date

2015-01-12

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS ELEGIBLE FOR AUTOLOGOUS TRANSPLANT

Interventions

Product Name: Carfilzomib Product Code: PR-171 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: CARFILZOMIB CAS Number: 868540-17-4 Other descriptive name: CARFILZOMIB Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years Newly diagnosed MM based on standard CRAB criteria (see appendix B). Patient 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 Life expectancy = 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 477 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid 2 cm Patients ineligible for autologous transplantation 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 Myocardial infarction or unstable angina = 4 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) 4.0 (Appendix A) Known history of allergy to Captisol ® (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to any of the required drugs or supportive treatments Invasive malignancy within the past 3 years Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the enrolment or place the subject at unacceptable risk.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy, in term of at least very good partial response (VGPR), of the combination of Carfilzomib and dexamethasone with cyclophosphamide or lenalidomide after 4 cycles of induction treatment in newly diagnosed MM patients eligible for autologous transplantation. (ASCT) ;Secondary Objective: To determine the stringent complete response (sCR) rate in the 3 arms after complete primary therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) in an explorative manner. To determine the safety in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine the survival in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine whether tumor response and outcome may change in subgroups with different baseline prognostic factors To determine the Minimal Residual Disease (MRD) To determine the survival after relapse ;Primary end point(s): All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group. ;Timepoint(s) of evaluation of this end point: Efficacy will be assessed by considering VGPR at cycle 4 in the 3 arms	—

Measure

Time frame

Main Objective: To determine the efficacy, in term of at least very good partial response (VGPR), of the combination of Carfilzomib and dexamethasone with cyclophosphamide or lenalidomide after 4 cycles of induction treatment in newly diagnosed MM patients eligible for autologous transplantation. (ASCT) ;Secondary Objective: To determine the stringent complete response (sCR) rate in the 3 arms after complete primary therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) in an explorative manner. To determine the safety in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine the survival in the 3 induction/consolidation arms and in the 2 maintenance arms. To determine whether tumor response and outcome may change in subgroups with different baseline prognostic factors To determine the Minimal Residual Disease (MRD) To determine the survival after relapse ;Primary end point(s): All patients will be included in the Intent-to-Treat (ITT) analysis. Efficacy will be assessed by considering VGPR at cycle 4 in the 3 arms. Assessment of VGPR rate will be performed according to the criteria of the International Myeloma Working Group. ;Timepoint(s) of evaluation of this end point: Efficacy will be assessed by considering VGPR at cycle 4 in the 3 arms

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Secondary

Measure	Time frame
Secondary end point(s): • Determine the rate of sCR in the 3 arms after complete primary therapy (induction, ASCT, consolidation) in an explorative manner • Determine the rate of adverse events in the 3 induction/consolidation arms and in the 2 maintenance arms. • Determine the progression-free survival at 2 years (2ys-PFS) • Determine the time to progression (TTP) • Determine the duration of response (DOR) • Determine the overall survival (OS) • Determine the time to next therapy (TNT) • Determine the Progression Free Survival-2 defined as the time from initial randomization (to first line therapy) until to second objective disease progression on next line treatment, or death from any cause • Determine the Minimal Residual Disease (MRD) measurement;Timepoint(s) of evaluation of this end point: see below E.5.2	—

Measure

Time frame

Secondary end point(s): • Determine the rate of sCR in the 3 arms after complete primary therapy (induction, ASCT, consolidation) in an explorative manner • Determine the rate of adverse events in the 3 induction/consolidation arms and in the 2 maintenance arms. • Determine the progression-free survival at 2 years (2ys-PFS) • Determine the time to progression (TTP) • Determine the duration of response (DOR) • Determine the overall survival (OS) • Determine the time to next therapy (TNT) • Determine the Progression Free Survival-2 defined as the time from initial randomization (to first line therapy) until to second objective disease progression on next line treatment, or death from any cause • Determine the Minimal Residual Disease (MRD) measurement;Timepoint(s) of evaluation of this end point: see below E.5.2

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Countries

Italy

Contacts

Public ContactDivisione di Ematologia

Università degli Studi di Torino-Dipartimento di Biotecnologie Molecolari e Scienze della salute

clinical.trials@unito.it+390116336107

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026