NCT02046070

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide tablets
DRUG	Ixazomib	Ixazomib capsules
DRUG	Dexamethasone	Dexamethasone tablets

Timeline

• Start date: 2014-03-05
• Primary completion: 2018-06-29
• Completion: 2018-06-29
• First posted: 2014-01-27
• Last updated: 2019-07-17
• Results posted: 2019-07-17

Locations

24 sites across 5 countries: United States, Australia, Greece, Poland, Sweden

Regulatory

• FDA-regulated drug study