Use of a novel chemotherapeutic regimen in an attempt to eradicate residual myeloma disease after a first autologous stem cell Transplantation.

Carfilzomib in combination with lenalidomide and dexamethasone – feasibility and efficacy of a new consolidation regimen in inducing and/or re-inducing minimal residual disease negativity in multiple myeloma patients after a first autologous stem cell transplant. A prospective, multicenter, interventional, open label, phase II Trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004778-16-AT

Enrollment

Registered

2017-12-19

Start date

2018-01-30

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Multiple Myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Trade Name: Kyprolis Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Carfilzomib CAS Number: 868540-17-4 Current Sponsor code: PR-171 Other descriptive name: CARFILZOMIB Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Anteceding therapeutic sequence of 4 to 6 cycles of an induction therapy followed by a treatment with high-dose melphalan (HD-MEL) and ASCT - = partial response before HD-MEL - = very good partial response and MRD-positivity after ASCT 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 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: One or more of the following ultra-high risk features at first diagnosis: - A Revised International Staging System (R-ISS) score (Palumbo 2015) of III at first diagnosis - Extended extramedullary disease (especially CNS involvement) - Plasma cell leukemia

Design outcomes

Primary

Measure	Time frame
Main Objective: To prospectively evaluate whether 3 or 6 cycles of a combination of carfilzomib, lenalidomide and dexamethasone (KRd) are an effective and feasible means to induce minimal residual disease (MRD) negativity in patients with multiple myeloma (MM) following their first autologous stem cell transplant (ASCT). Presence or absence of MRD will be demonstrated by next-generation multiparameter flow cytometry (MFC).;Secondary Objective: To study whether 3 or 6 cycles of KRd re-induce MRD negativity in patients in MM patients who (following a first set of KRd) have achieved, and then have lost a negative MRD status once after completion of a first ASCT.;Primary end point(s): The primary endpoint of the study will be achieved if a response rate of at least 60% (MRD-negative patients as determined by MFC with a threshold of sensitivity of 10-5) can be statistically confirmed in the modified intention to treat population. ;Timepoint(s) of evaluation of this end point: after the first 3 or 6 cycles of KRD	—

Measure

Time frame

Main Objective: To prospectively evaluate whether 3 or 6 cycles of a combination of carfilzomib, lenalidomide and dexamethasone (KRd) are an effective and feasible means to induce minimal residual disease (MRD) negativity in patients with multiple myeloma (MM) following their first autologous stem cell transplant (ASCT). Presence or absence of MRD will be demonstrated by next-generation multiparameter flow cytometry (MFC).;Secondary Objective: To study whether 3 or 6 cycles of KRd re-induce MRD negativity in patients in MM patients who (following a first set of KRd) have achieved, and then have lost a negative MRD status once after completion of a first ASCT.;Primary end point(s): The primary endpoint of the study will be achieved if a response rate of at least 60% (MRD-negative patients as determined by MFC with a threshold of sensitivity of 10-5) can be statistically confirmed in the modified intention to treat population. ;Timepoint(s) of evaluation of this end point: after the first 3 or 6 cycles of KRD

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Secondary

Measure	Time frame
Secondary end point(s): To study whether, by the use of 3 or 6 cycles of KRd, MRD negativity can be re-achieved in MM patients who achieved and lost their negative MRD status once after completion of a first ASCT. ;Timepoint(s) of evaluation of this end point: To study whether, by the use of 3 or 6 cycles of KRd, MRD negativity can be re-achieved in MM patients who achieved and lost their negative MRD status once after completion of a first ASCT.	—

Measure

Time frame

Secondary end point(s): To study whether, by the use of 3 or 6 cycles of KRd, MRD negativity can be re-achieved in MM patients who achieved and lost their negative MRD status once after completion of a first ASCT. ;Timepoint(s) of evaluation of this end point: To study whether, by the use of 3 or 6 cycles of KRd, MRD negativity can be re-achieved in MM patients who achieved and lost their negative MRD status once after completion of a first ASCT.

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Countries

Austria

Contacts

Public ContactStudienbuero

Office of Clinical Trials, Elisabethinen Hospital, Ordensklinikum Linz

MRD_STUDY_MM@ordensklinikum.at4373276764425

Outcome results

None listed

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