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Multiple MyelomaPhase 2IFM2008NCT01206205

Frontline Therapy in de Novo Multiple Myeloma Patients Under 65

A Phase 2 study testing Lenalidomide, Bortezomib in people with Multiple Myeloma, run by University Hospital, Toulouse at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide, Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
9 sitesFrance
Study dates
Aug 2009to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
  • Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
  • Subjects must have measurable disease requiring systemic therapy.
  • Male or female subject 18 years of age or older
  • Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group Performance Status score ≤2)
  • Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to therapy. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women must also agree to ongoing pregnancy testing
  • Men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential.

Who cannot join

  • Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in a 2-week period). Two weeks must have elapsed since the date of the last radiotherapy treatment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
  • AL amylo
  • ≥Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
  • Renal insufficiency (serum creatinine >2.5 mg/dL)
  • Evidence of mucosal or internal bleeding and/or platelet refractory
  • Platelet count <70,000 per µL
Show all 19Show fewer
  • ANC < 1000 cells/mm3
  • AST or ALT greater than or equal to 2 x ULN
  • Total bilirubin >3 × ULN
  • Myocardial infarction within 6 months prior to enrollment according to NYHY Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Clinically relevant active infection or serious co-morbid medical conditions
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
  • Female subject who is pregnant or breast-feeding
  • Serious medical or psychiatric illness likely to interfere with participation in study
  • Uncontrolled diabetes mellitus
  • Known HIV infection
  • Known active hepatitis B or C viral infection
  • Known intolerance to steroid therapy
  • History of allergy to any of the study medications, their analogues, or excipients in the various formulations

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Centre François Baclesse

    Caen, 14076

  • University Hospital of Dijon, Hôpital des Enfants

    Dijon, 21000

  • University Hospital of Grenoble, Hôpital A.Michallon, BP 217 X

    Grenoble, 38043

  • University Hospital Of Lille, Hôpital Claude Huriez

    Lille, 59037

  • Institut Paoli Calmette

    Marseille, 13273

  • University Hospital of Bordeaux, "Hôpital du Haut Lévêque "

    Pessac, 33604

  • University Hospital of Toulouse, Purpan

    Toulouse, 31059

  • Hôpital Bretonneau, Tours

    Tours, 37044

  • Hôpitaux de Brabois Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: IFM2008: Frontline Therapy in de Novo Multiple Myeloma Patients Under 65, (a Phase 2 Multicenter Trial)

The purpose of this Phase 2 study is to evaluate the efficacy and safety of treatment with bortezomib, lenalidomide and dexamethasone in patients with untreated multiple myeloma. This study will evaluate whether the addition of lenalidomide to bortezomib and dexamethasone will increase the Complete Response (CR)/ very good partial response (VGPR) rate before and after High Dose Therapy (HDT) with ASCT.

Read the detailed description

Patients will receive 3 induction cycles of bortezomib, lenalidomide and dexamethasone (VRD) followed by high dose melphalan and autologous stem cell transplantation. Two months after haematological recovery, patients will receive 2 consolidation cycles of VRD and maintenance therapy for 1 year with lenalidomide

Being tested
Lenalidomide, Bortezomib
Keywords
De novo Multiple Myeloma, Bortezomib, Lenalidomide, induction therapy, consolidation therapy, maintenance therapy, High dose therapy, frontline therapy including new drugs and high dose therapy
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide, BortezomibDrug

    Also called Lenalidomide (REVLIMID®), Bortezomib (VELCADE®)

    Induction:

    3 cycles of 21 days of Dexamethasone : 40 mg/j, days 1, 8 et 14 Bortezomib (Velcade®) : 1,3 mg/m2/d, days 1, 4, 8, et 11 Lenalidomide (Revlimid®) :25 mg/d, days 1 to 14

    Consolidation (2 months After ASCT):

    2 cycles of 21 days of Lenalidomide (Revlimid®) 25 mg/j, days 1 à 14 Bortezomib (Velcade®) 1,3 mg/m2/d, days 1, 4, 8, et 11 Dexamethasone 40 mg/j, days 1, 8 et 14

    Maintenance Phase:

    3 to 8 weeks after consolidation. Cycle length: 28 days Lenalidomide (Revlimid®) 10 mg/d until 12 months

Study groups in NCT01206205
Study groupRoleWhat they receive
Lenalidomide, BortezomibExperimental3 induction cycles of bortezomib, lenalidomide and dexamethasone (VRD) followed by high dose melphalan and autologous stem cell transplantation. Two months after haematological recovery, patients will receive 2 consolidation cycles of VRD and maintenance therapy for 1 year with lenalidomide.
Receives: Drug: Lenalidomide, Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the best response after consolidation

    Evaluate the best response achieved , according to the IMWG uniform criteria, after consolidation treatment.

    Measured: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

Secondary outcomes (5)

  1. Response Evaluation after 3 cycles

    Evaluate the complete and very good partial response rates of the combination of bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients after 3 cycles.

    Measured: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

  2. Safety and tolerability : number and nature of Adverse Events

    Determine the safety and tolerability of the drug combination in this patient populations.

    Measured: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

  3. Stem Cells Collection

    Evaluate the faisability and quality of the peripheral stem cells collection.

    Measured: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

  4. Response After HDT-ASCT and 2 cycles

    Evaluate the complete and very good partial response rates 2 months after HDT with ASCT and after 2 cycles of consolidation treatment.

    Measured: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

  5. Progression Free Survival

    Evaluate the progression free survival, the overall survival, time to progression and duration of response.

    Measured: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01206205
Sponsor's protocol ID
0805603
Acronym
IFM2008
Status last verified
May 2017
First submitted
17 Sep 2010
Last updated
12 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Roussel M, Lauwers-Cances V, Robillard N, Hulin C, Leleu X, Benboubker L, Marit G, Moreau P, Pegourie B, Caillot D, Fruchart C, Stoppa AM, Gentil C, Wuilleme S, Huynh A, Hebraud B, Corre J, Chretien ML, Facon T, Avet-Loiseau H, Attal M. Front-line transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma: a phase II study by the Intergroupe Francophone du Myelome. J Clin Oncol. 2014 Sep 1;32(25):2712-7. doi: 10.1200/JCO.2013.54.8164. Epub 2014 Jul 14.

    PubMed 25024076

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide, Bortezomib in people with Multiple Myeloma, run by University Hospital, Toulouse at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the best response after consolidation (time frame: 6 to 8 months after start of induction for each patient = after consolidation therapy for all patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01206205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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