Randomisierte Phase III Studie für Patienten mit Multiplem Myelom zur Untersuchung zweier Therapieschemata einer Bortezomib-basierten Induktionsthearpie und einer Lenalidomid-Konsolidierungstherapie gefolgt von einer Erhaltungstherapie mit Lenalidomid

Randomised phase III trial for previously untreated multiple myeloma to evaluate two regimens of bortezomib based induction therapy and lenalidomide consolidation followed by lenalidomide maintenance treatment - MM5

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019173-16-DE

Enrollment

604

Registered

2010-02-23

Start date

2010-07-08

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

multiple myeloma (symptomatic, newly diagnosed)

Interventions

Trade Name: Velcade Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BORTEZOMIB CAS Number: 179324-69-7 Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • newly-diagnosed symptomatic multiple myeloma ("CRAB" criteria) • measurable disease • age 18 - 70 years (both included) • WHO performance status 0-2 (WHO=3 is allowed when caused by myeloma) • negative pregnacy test • patients must be willing and capable to use adequate contraception • written informed consent 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 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: • hypersensitivity to any relevant medication within the trial • systemic AL-amyloidosis • previous chemotherapy or radiotherapy during the past 5 years • severe cardiac dysfunction • significant hepatic dysfunction • patients known to be HIV-positive • other malignancy during the past 5 years • peripheral neuropathy CTC grade 2 or higher

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.) Demonstration of non-inferiority of VCD induction therapy compared to PAd induction therapy with respect to response rate (very good partial remission or better; response criteria of the International Myeloma Working Group, IMWG). 2.) Determination of the best of four treatment strategies with respect to progression-free survival (PFS). The four treatment strategies are defined by PAd vs. VCD induction treatment, standard intensification therapy, lenalidomide consolidation and maintenance treatment with lenalidomide for 2 years vs. lenalidomide until CR. ; Secondary Objective: - overall survival rates (OS) - response rates after lenalidomide consolidation treatment - best response rates - toxicity during induction treatment, lenalidomide consolidation and maintenance treatment with respect to adverse events of CTCAE grade >= 3 Additional descriptive and explorative analysis of Bortezomib administration i.v. versus s.c. ; Primary end point(s): Primary endpoints: 1) Response to treatment (very good partial remission or better) after induction therapy 2) Progression free survival (i.e., time from randomisation to progression or death from any cause whichever occurs first). ; Timepoint(s) of evaluation of this end point: 1) After induction therapy 2) Progression free survival (i.e., time from randomisation to progression or death from any cause whichever occurs first).	—

Measure

Time frame

Main Objective: 1.) Demonstration of non-inferiority of VCD induction therapy compared to PAd induction therapy with respect to response rate (very good partial remission or better; response criteria of the International Myeloma Working Group, IMWG). 2.) Determination of the best of four treatment strategies with respect to progression-free survival (PFS). The four treatment strategies are defined by PAd vs. VCD induction treatment, standard intensification therapy, lenalidomide consolidation and maintenance treatment with lenalidomide for 2 years vs. lenalidomide until CR. ; Secondary Objective: - overall survival rates (OS) - response rates after lenalidomide consolidation treatment - best response rates - toxicity during induction treatment, lenalidomide consolidation and maintenance treatment with respect to adverse events of CTCAE grade >= 3 Additional descriptive and explorative analysis of Bortezomib administration i.v. versus s.c. ; Primary end point(s): Primary endpoints: 1) Response to treatment (very good partial remission or better) after induction therapy 2) Progression free survival (i.e., time from randomisation to progression or death from any cause whichever occurs first). ; Timepoint(s) of evaluation of this end point: 1) After induction therapy 2) Progression free survival (i.e., time from randomisation to progression or death from any cause whichever occurs first).

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Secondary

Measure	Time frame
Secondary end point(s): 1) Overall survival rates 2) response after lenalidomide consolidation treatment 3) best response rates 4) toxicity during induction treatment, lenalidomide consolidation and maintenance treatment with respect to adverse events CTC grade 3 or higher Additional descriptive and explorative analysis of Bortezomib administration i.v. versus s.c. ;Timepoint(s) of evaluation of this end point: any time	—

Measure

Time frame

Secondary end point(s): 1) Overall survival rates 2) response after lenalidomide consolidation treatment 3) best response rates 4) toxicity during induction treatment, lenalidomide consolidation and maintenance treatment with respect to adverse events CTC grade 3 or higher Additional descriptive and explorative analysis of Bortezomib administration i.v. versus s.c. ;Timepoint(s) of evaluation of this end point: any time

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Countries

Germany

Contacts

Public ContactGMMG Studiensekretariat

GMMG Study Office

studiensekretariat.gmmg@med.uni-heidelberg.de00496221568198/568015

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 10, 2026