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

Overview
Related items

The main objectives of this trial are: 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.

SEEK ID: https://cgnbonn.fdm.digital-medicine.org/projects/14

Public web page: Not specified

Organisms: No Organisms specified

NFDI4Health PIs: Cristoph Scheid

Trial Project start date: 1st Jun 2010

Trial Project end date: 11th Mar 2017

Extended Metadata (Nfdi4Health MDS 3.3)

Expand All Collapse All

Id of the project(*) : 29321

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : 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
Language of the title/name : English

Acronym(s) of the Project

Acronym : MM5
Language of the acronym : English

Description(s) of the Project

Description : The main objectives of this trial are: 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Not specified

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Cristoph
Family name(s)(*) : Scheid
Digital identifier(s)
Identifier(*) : 0009-0007-6539-226X
Scheme(*) : ORCID
Email address : christoph.scheid@uk-koeln.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Klinik I für Innere Medizin, University Hospital Cologne
Address : Kerpener Straße 62 50937 Cologne, Germany
Web page : https://innere1.uk-koeln.de/
Digital identifier(s)
Identifier(*) : 05mxhda18
Scheme(*) : ROR

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Contact
Given name(*) : Cristoph
Family name(s)(*) : Scheid
Digital identifier(s)
Identifier(*) : 0009-0007-6539-226X
Scheme(*) : ORCID
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Klinik I für Innere Medizin, University Hospital Cologne
Address : Kerpener Straße 62 50937 Cologne, Germany
Web page : https://innere1.uk-koeln.de/
Digital identifier(s)
Identifier(*) : 05mxhda18
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitätsklinikum Heidelberg
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Universitätsklinikum Heidelberg
Address : Im Neuenheimer Feld 672 69120 Heidelberg Gebäude 6672, Germany
Web page : https://www.klinikum.uni-heidelberg.de/
Digital identifier(s)
Identifier(*) : 013czdx64
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2010-019173-16

Type of the registry(*) : ISRCTN
Identifier(*) : ISRCTN05622749

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : multiple myeloma (symptomatic, newly diagnosed)
Terminology/classification(*) : ICD-10
Code of the health condition or disease : C90.00
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Neoplasms (II)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 1 June 2010
End date : 11 March 2017
Mono- or multicentric? : Multicentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 70
Unit of age(*) : Years
Eligible gender : Male, Female
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 pregnancy test; - patients must be willing and capable to use adequate contraception; - written informed consent
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
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Arm A1
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Baseline of Arm A1 (PAd induction, lenalidomide maintenance for 2 years)
Name(s) of the arm(s) associated with the given intervention : PAd (arms A1+B1)
Name of the intervention(*) : Arm B1
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Baseline of arm B1 (PAd induction, lenalidomide maintenance if no CR)
Name(s) of the arm(s) associated with the given intervention : PAd (arms A1+B1)
Name of the intervention(*) : Arm A2
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Baseline of arm A2 (VCD induction, lenalidomide maintenance for 2 years)
Name(s) of the arm(s) associated with the given intervention : VCD (arms A2+B2)
Name of the intervention(*) : Arm B2
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Baseline of arm B2 (VCD induction, lenalidomide maintenance if no CR)
Name(s) of the arm(s) associated with the given intervention : VCD (arms A2+B2)
Name of the intervention(*) : PAd (arms A1+B1)
Type of the intervention : Drug (including placebo)
Additional information about the intervention : All patients randomized to study arms A1 and B1 received PAd for induction treatment, primary cohort.
Name(s) of the arm(s) associated with the given intervention : Arm A1, Arm B1, Standard Intensification + consolidation post PAd (A1+B1)
Name of the intervention(*) : VCD (arms A2+B2)
Type of the intervention : Drug (including placebo)
Additional information about the intervention : All patients randomized to study arms A2 and B2 received VCD for induction treatment, primary cohort.
Name(s) of the arm(s) associated with the given intervention : Arm A2, Arm B2, Standard Intensification + consolidation post VCD (Arm A2+B2
Name of the intervention(*) : Standard Intensification + consolidation post PAd (A1+B1)
Type of the intervention : Other
Additional information about the intervention : Standard mobilization + ASCT + Lenalidomide consolidation after PAd induction.
Name(s) of the arm(s) associated with the given intervention : PAd (arms A1+B1), Maintenance Arm A1, Maintenance Arm B1
Name of the intervention(*) : Standard Intensification + consolidation post VCD (Arm A2+B2
Type of the intervention : Other
Additional information about the intervention : Standard mobilization + ASCT + Lenalidomide consolidation after VCD induction
Name(s) of the arm(s) associated with the given intervention : VCD (arms A2+B2), Maintenance Arm A2, Maintenance Arm B2
Name of the intervention(*) : Maintenance Arm A1
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Lenalidomide maintenance for 2 years after PAd induction, standard intensification (ASCT) and lenalidomide consolidation
Name(s) of the arm(s) associated with the given intervention : Standard Intensification + consolidation post PAd (A1+B1)
Name of the intervention(*) : Maintenance Arm B1
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Lenalidomide maintenance if no CR; after PAd induction, standard intensification (ASCT) and lenalidomide consolidation
Name(s) of the arm(s) associated with the given intervention : Standard Intensification + consolidation post PAd (A1+B1)
Name of the intervention(*) : Maintenance Arm A2
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Lenalidomide maintenance for 2 years after VCD induction, standard intensification (ASCT) and lenalidomide consolidation
Name(s) of the arm(s) associated with the given intervention : Standard Intensification + consolidation post VCD (Arm A2+B2
Name of the intervention(*) : Maintenance Arm B2
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Lenalidomide maintenance if no CR after VCD induction, standard intensification (ASCT) and lenalidomide consolidation
Name(s) of the arm(s) associated with the given intervention : Standard Intensification + consolidation post VCD (Arm A2+B2
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Response to treatment (very good partial remission or better) after induction therapy
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : After induction therapy
Name of the outcome measure(*) : Progression free survival (i.e., time from randomisation to progression or death from any cause whichever occurs first)
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : Progression free survival (i.e., time from randomisation to progression or death from any cause whichever occurs first).
Name of the outcome measure(*) : Overall survival rates
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Any time
Name of the outcome measure(*) : Response after lenalidomide consolidation treatment
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Any time
Name of the outcome measure(*) : Best response rates
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Any time
Name of the outcome measure(*) : Toxicity during induction treatment, lenalidomide consolidation and maintenance treatment with respect to adverse events CTC grade 3 or higher
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Any time
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

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

Related items