Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MM5
Study information
Scientific title
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
Acronym
MM5
Study hypothesis
The MM5 trial is designed to address two independent primary objectives. The primary
objectives of the study are:
1. Demonstration of non-inferiority of VCD (bortezomib, cyclophosphamide, dexamethasone) induction therapy compared to PAd (bortezomib, adriamycin, dexamethasone) 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 versus VCD induction treatment, standard intensification therapy, lenalidomide consolidation and maintenance treatment with lenalidomide for 2 years versus lenalidomide until complete response (CR).
Ethics approval
Ethikkommission der Medizinischen Fakultaet Heidelberg, University of Heidelberg, pending as of 16/04/2010
Study design
Prospective multicentre multinational randomised parallel group open phase III clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multiple myeloma
Intervention
Patients are randomised into four treatment arms (A1, A2, B1, B2).
Patients included in arms A1/B1 are treated with 3 cycles PAd (bortezomib 1.3 mg/m^2 intravenous [iv] on days 1, 4, 8 and 11, doxorubicin 9 mg/m^2 iv on days 1 - 4, dexamethasone [Dex] orally [po] 20 mg/d on days 1 - 4, 9 - 12 and 17 - 20).
Patients in arm A2/B2 are treated with 3 cycles VCD (bortezomib 1.3 mg/m^2 iv on days 1, 4, 8 and 11, cyclophosphamide 900 mg/m^2 iv on day 1, dexamethasone po 40 mg/d on days 1 - 2, 4 - 5, 8 - 9, 11 - 12).
Standard intensification treatment will be done according to local protocols.
Thereafter, two cycles of lenalidomide 25 mg/d on days 1 - 21 are given, followed by a lenalidomide maintenance treatment (lenalidomide orally [po] 10 mg/d in the first three months, thereafter 15 mg/d). In arms A1 and A2 lenalidomide maintenance will be given for a period of 2 years, in arms B1 and B2 until a CR is reached.
Intervention type
Drug
Phase
Phase III
Drug names
VCD (bortezomib, cyclophosphamide, dexamethasone), PAd (bortezomib, adriamycin, dexamethasone)
Primary outcome measures
1. Response to treatment (very good partial remission or better) after induction therapy, measured after induction therapy
2. Progression-free survival (i.e., time from randomisation to progression or death from any
cause whichever occurs first), measured at several timepoints during study and follow up if there is a progression of the disease
Secondary outcome measures
1. Overall survival defined as time from randomisation to death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
2. Response rates (response rates will be assessed using the following subcategories: SD, MR, PR, VGPR [with subgroup nCR], CR, sCR, mCR). Response measured after induction, after intensification, after consolidation and during maintenance.
3. Toxicity ([serious] adverse events CTC grade 3 and grade 4, CTC-AE v4.0), measured at induction, consolidation and maintenance treatment
Overall trial start date
15/05/2010
Overall trial end date
15/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Confirmed diagnosis of multiple myeloma requiring systemic therapy
2. Measurable disease
3. Aged 18 - 70 years inclusive, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
504
Participant exclusion criteria
1. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression
2. Severe cardiac dysfunction
3. Significant hepatic dysfunction
4. Patients known to be human immunodeficiency virus (HIV)-positive
5. Patients with active, uncontrolled infections
6. Patients with peripheral neuropathy or neuropathic pain, Common Toxicity Criteria (CTC) grade 2 or higher
7. Patients with a history of active malignancy during the past 5 years
8. Systemic amyloid light chain (AL) amyloidosis
9. Pregnancy and lactation
Recruitment start date
15/05/2010
Recruitment end date
15/05/2016
Locations
Countries of recruitment
France, Germany
Trial participating centre
Universitätsklinikum Heidelberg
Heidelberg
69120
Germany
Sponsor information
Organisation
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Sponsor details
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Celgene (Europe)
Alternative name(s)
Celgene Corporation
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Janssen Cilag (Europe)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Chugai (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Binding Site (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary