NCT03908138

RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Multiple myeloma (MM) is a common malignant hematology disease. The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) significantly improved the survival of MM patients. IMiDs have multiple effects in MM therapy. Except for direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. Lenalidomide, a kind of IMiDs, was usually used in the therapy of relapsed/refractory MM. The efficacy and safety of RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM still needs to be further validated.

Detailed description

The therapy regimens of MM were very limited before 2000, mainly including VAD (vincristine, doxorubicin, dexamethasone), methylpheniram, corticosteroids and autologous stem cell transplantation (ASCT). The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) in the 2000's significantly improved the survival of MM patients. Combined chemotherapy containing new drugs has become the first-line therapy for the treatment of newly diagnosed MM patients. In addition to direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. The effects on immune system include reducing TNF-α, IL-1β, IL-6 and IL-12, increasing production of IL-2 and IFN-γ, increasing T cell initiation, enhancing the absorption of tumor antigen by dendritic cells (DCs), enhancing the efficiency of antigen presentation, inhibiting regulatory T cells (Treg), and enhancing the activity of natural killer cells (NK) and NKT cells. Lenalidomide, a kind of IMiDs, also have the effects on osteoclasts, which are important in bone disease in MM patients. In 2006, the combination of lenalidomide and dexamethasone (RD) was approved in the United States for the treatment of relapsed/refractory MM. The RD regimen was approved for the treatment of newly diagnosed MM patients in 2015. Four lenalidomide-containing triple drug regimens were approved for the treatment of relapsed/refractory MM from 2015 to 2016. However, the application of lenalidomide-containing triple drug regimens in newly diagnosed patients with multiple myeloma needs to be further validated. Therefore, we designed the randomized controlled clinical study and aimed to compare the efficacy and safety between RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) and VDD (bortezomib, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM.

Conditions

• Hematologic Neoplasms
• Multiple Myeloma
• Efficacy
• Safety

Interventions

Type	Name	Description
DRUG	RDD	Lenalidomide: 25mg, po, d1-21， Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20-40mg, po, d1，d8，d15，d22
DRUG	VDD	Bortezomib:1.3mg/m2，ih，d1，d4，d8，d11 Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20 mg, ivgtt, d1, 2, 4, 5, 8, 9, 11,12

Timeline

• Start date: 2019-03-30
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-04-09
• Last updated: 2019-11-29

Locations

1 site across 1 country: China