Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06) (IFM2013-06)
|ClinicalTrials.gov Identifier: NCT01936532|
Recruitment Status : Active, not recruiting
First Posted : September 6, 2013
Last Update Posted : March 28, 2017
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Multiple Myeloma||Drug: MLN9708 Drug: Lenalidomide Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years|
|Actual Study Start Date :||November 12, 2014|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2020|
|Experimental: assessment of treatment lenalidomide, dexamethasone,MLN9708||
Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22 of a 28-day cycle.
Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months.
- To evaluate the stringent Complete Response (sCR) rate of the combination of MLN9708, Lenalidomide and Dexamethasone in newly diagnosed multiple myeloma (MM) patients after extended consolidation therapy [ Time Frame: sixteen months ]
- To evaluate the overall response rate after induction therapy [ Time Frame: after 63 days ]
- To evaluate the safety Evaluate the safety [ Time Frame: after 63 days ]
Descriptive statistics of treatment duration cumulative dose, dose intensity and relative dose intensity will be presented.
Treatment emergent adverse events will be summarized by period (induction, consolidation and maintenance) and overall.
Overall adverse events will be summarized by system organ class and preferred term and by severity (worst toxicity grade owing to the NCI CTCAE v4.0).
- To evaluate the quality of stem cell harvest [ Time Frame: after 84 days ]
according to institutional practice, participants must collect a minimum CD34 count of > 5x106 cells/kg. In case of insufficient collection, collection of a minimum CD34 count of > 2x106 cells/kg will be allowed.
Thus the number of cells collected will be evaluated
- To evaluate the overall response rate after high-dose therapy (prior to consolidation) [ Time Frame: after 84 days ]
- To evaluate the overall response rate after consolidation therapy [ Time Frame: after 270 days ]
- To evaluate the feasibility of maintenance with MLN9708 [ Time Frame: after 270 days ]number of dose
- To evaluate duration of response, progression-free and overall survival [ Time Frame: five years and a half ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936532
|CHRU - Hôpital du Haut Lévêque|
|Bordeaux pessac, France, 33604|
|Dijon, France, 21000|
|Centre hospitalier départemental Vendée|
|La Roche Sur Yon, France, 85925|
|CHRU - Hôpital Claude Huriez|
|Lille, France, 59037|
|Nantes University Hospital|
|Nantes, France, 44093|
|Paris, France, 75 571|
|Centre Hospitalier Lyon sud|
|Pierre Benite, France, 69495|
|Pole IUC Oncopole CHU|
|Toulouse cedex 9, France, 31059|
|CHRU - Hôpital Bretonneau|
|Tours, France, 37044|
|CHRU - Hôpitaux de Brabois|
|Vandoeuvre Les Nancy, France, 54511|
|Principal Investigator:||Philippe MOREAU||Nantes University Hospital|