Frontline Therapy in de Novo Multiple Myeloma Patients Under 65

Multiple Myeloma Clinical Trial

— IFM2008  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206205
• Other study ID #: 0805603
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2010
• Last updated: May 10, 2017
• Start date: August 2009
• Est. completion date: October 2012

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide, Bortezomib
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

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen, cedex 5
France	University Hospital of Dijon, Hôpital des Enfants	Dijon
France	University Hospital of Grenoble, Hôpital A.Michallon, BP 217 X	Grenoble Cedex 09
France	University Hospital Of Lille, Hôpital Claude Huriez	Lille Cedex
France	Institut Paoli Calmette	Marseille Cedex
France	University Hospital of Bordeaux, "Hôpital du Haut Lévêque "	Pessac
France	University Hospital of Toulouse, Purpan	Toulouse
France	Hôpital Bretonneau, Tours	Tours Cedex
France	Hôpitaux de Brabois Nancy	Vandoeuvre cedex

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Celgene Corporation, Janssen-Cilag Ltd.

Country where clinical trial is conducted

France, 

References & Publications (1)

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 transpl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the best response after consolidation	Evaluate the best response achieved , according to the IMWG uniform criteria, after consolidation treatment.	6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Secondary	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.	6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Secondary	Safety and tolerability : number and nature of Adverse Events	Determine the safety and tolerability of the drug combination in this patient populations.	6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Secondary	Stem Cells Collection	Evaluate the faisability and quality of the peripheral stem cells collection.	6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Secondary	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.	6 to 8 months after start of induction for each patient = after consolidation therapy for all patients
Secondary	Progression Free Survival	Evaluate the progression free survival, the overall survival, time to progression and duration of response.	6 to 8 months after start of induction for each patient = after consolidation therapy for all patients