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Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
An Open-Label, Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma Requiring Systemic Treatment

Clinical Trial Summary

This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma (RRMM).

Clinical Trial Description

The investigational drug being tested in this study is called MLN9708 also known as Ixazomib. This study will look at disease response rates and safety in people who take ixazomib in addition to cyclophosphamide and dexamethasone. NDMM participants will be randomly assigned (by chance, like flipping a coin) to one of two treatment groups and RRMM participants will be assigned to a third group:

- NDMM - ixazomib (MLN9708) 4.0 mg + cyclophosphamide 300 mg/m^2 + dexamethasone 40 mg

- NDMM - ixazomib (MLN9708) 4.0 mg + cyclophosphamide 400 mg/m^2 + dexamethasone 40 mg

- RRMM - ixazomib (MLN9708) 4.0 mg + cyclophosphamide 300 mg/m^2 + dexamethasone 40 mg

The study enrolled 148 participants. This multi-centre trial will be conducted in the United States, European Union, and Australia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02046070
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date March 5, 2014
Completion date June 29, 2018
View Details
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