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NCT01936532: IFM2013-06
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
Phase 2 trial testing MLN9708 in Newly Diagnosed Multiple Myeloma in 42 participants. Completed in 4 June 2020.
1 March 2019
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 12 November 2014 |
| Primary completion | 1 March 2019 |
| Estimated completion | 4 June 2020 |
| Sites | 10 locations across France |
Drugs / interventions tested
- MLN9708 — full drug profile →
- Lenalidomide — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Newly Diagnosed Multiple Myeloma — all drugs for Newly Diagnosed Multiple Myeloma →
Sponsor
Nantes University Hospital
Who can join
Adults 18 to 66, any sex, with Newly Diagnosed Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Spotlight on ixazomib: potential in the treatment of multiple myeloma.
Muz B, Ghazarian RN, Ou M, Luderer MJ, et al · · 2016 · cited 87× · PMID 26811670 · DOI 10.2147/dddt.s93602 -
An evidence-based review of ixazomib citrate and its potential in the treatment of newly diagnosed multiple myeloma.
Offidani M, Corvatta L, Caraffa P, Gentili S, et al · · 2014 · cited 40× · PMID 25302026 · DOI 10.2147/ott.s49187 -
The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift?
Kazandjian D, Mo CC, Landgren O, Richardson PG. · · 2020 · cited 25× · PMID 32501533 · DOI 10.1111/bjh.16764 -
Posttransplant maintenance therapy in multiple myeloma: the changing landscape.
Sengsayadeth S, Malard F, Savani BN, Garderet L, et al · · 2017 · cited 25× · PMID 28338672 · DOI 10.1038/bcj.2017.23 -
Trial Watch: Proteasomal inhibitors for anticancer therapy.
Obrist F, Manic G, Kroemer G, Vitale I, et al · · 2015 · cited 17× · PMID 27308423 · DOI 10.4161/23723556.2014.974463
Verify or expand the search:
- PubMed search for NCT01936532
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MLN9708
Trials testing the same drug.
- NCT03731832 — Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory · Phase 2 · completed
- NCT02477215 — Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma · Phase 1, PHASE2 · completed
- NCT02384746 — Phase I Study of the Combination of MLN9708 and Fulvestrant · Phase 1 · terminated
- NCT02169791 — Nonmyeloablative Haploidentical Transplant Followed by MLN9708 · Phase 2 · completed
- NCT02042989 — MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies · Phase 1 · completed
Other recruiting trials for Newly Diagnosed Multiple Myeloma
Currently open trials in the same condition.
- NCT06679101 — A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab · Phase 3 · recruiting
- NCT06682156 — Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients · recruiting
- NCT05259553 — Biomarkers in Multiple Myeloma · NA · recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
- NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
- NCT06681363 — Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelod · not yet recruiting
- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
- NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01936532 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 2 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01936532.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing