NCT01919086

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if researchers could get the same good results with less toxicity by using this new approach. We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given together at the same time are effective. Most physicians therefore treat patients with multiple myeloma with the 3 drug combination. However, the researchers also know that the three drugs given together result in more side effects than when only 2 drugs (bortezomib and dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that all patients may not necessarily need the three drugs to have good results. In this study, the researchers will first treat your disease with bortezomib and dexamethasone. If the disease is not well controlled with these 2 drugs, only then the third drug, lenalidomide, will be added. By using this sequential approach we may reach the same good results with fewer side effects.

Conditions

• Multiple Myeloma (MM)

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22
DRUG	Dexamethasone	Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
DRUG	Lenalidomide	Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression

Timeline

• Start date: 2013-08-06
• Primary completion: 2024-05-16
• Completion: 2024-05-16
• First posted: 2013-08-08
• Last updated: 2026-03-02
• Results posted: 2026-03-02

Locations

7 sites across 1 country: United States