RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908138
• Other study ID #: ShandongPH03
• Status: Recruiting
• Phase: Phase 4
• Start date: March 30, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2019
• Source: Shandong Provincial Hospital
• Contact: Xin Wang, PhD, MD
• Phone: +86-531-68778331
• Email: xinw[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of symptomatic (active) MM;

• Ages =18 years old, =65 years old;

• ECOG score: 0-2;

• Liver function: transaminase=2.5×upper limit of normal value,bilirubin=1.5×upper limit of normal value;

• Renal function: serum creatinine is 44-176 mmol/L;

• LVEF=50%;

• New York Heart Association (NYHA) heart function classification is I-II grade;

• Signed informed consent.

Exclusion Criteria:

• Severe complications or severe infection;

• Severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;

• Severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;

• Patients participate in other clinical studies;

• Patients are not suitable for the study;

• Other contraindications for ASCT therapy.

Related Conditions & MeSH terms

• Efficacy
• Hematologic Neoplasms
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Safety

Intervention

Drug:
• RDD
Lenalidomide: 25mg, po, d1-21, Pegylated Liposomal Doxorubicin: 30-40mg/m2,ivgtt, d1 Dexamethasone: 20-40mg, po, d1,d8,d15,d22
• 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

Locations

Country	Name	City	State
China	Department of Hematology, Provincial Hospital Affiliated to Shandong University	Jin'an	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Incidence of Treatment-Emergent Adverse Events	At 3 months, 5 months and 8 months
Primary	complete response (CR)	meeting the standard IMWG response criteria (CR and VGCR) of NCCN guidelines (Version2. 2019)	At 8 months
Primary	partial remission (PR)	meeting the standard IMWG response criteria (PR) of NCCN guidelines (Version2. 2019)	At 8 months
Secondary	Progressive free survival	the length of time during and after the treatment of MM that a patient lives with the disease but it does not get worse	At 3 months, 5 months, 8 months, 12 months, 18 months, 24 months and 36 months
Secondary	overall survival (OS)	the percentage of MM patient who are alive after 3 years.	At 3 months, 5 months, 8 months, 12 months, 18 months, 24 months and 36 months