Condition category
Cancer
Date applied
16/04/2010
Date assigned
27/04/2010
Last edited
27/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hartmut Goldschmidt

ORCID ID

Contact details

Universitätsklinikum Heidelberg
Medizinische Klinik V und Nationales Centrum für Tumorerkrankungen (NCT)
Im Neuenheimer Feld 410
Heidelberg
69120
Germany

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

http://www.med.uni-heidelberg.de/

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

Publication citations

Additional files

Editorial Notes