Clinical trial NCT02086942: Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.
Official title: Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to August 2017.Firstly, All patients included will provide written informed consent. Secondly, they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of four 4-week cycles of induction therapy followed by intensive therapy with another five modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be followed up for 24 months after chemotherapy. The investigators will record all the laboratory and clinical investigations to assess response at different points of the study. We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version 3.0.Response categories were based on the International Myeloma Working Group uniform response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.


Eligibility criteria: Inclusion Criteria:

* Patients with previously untreated symptomatic MM
* 18 years of age or older, regardless of gender
* secretory MM with measurable diseases
* Karnofsky Performance Status≥50%（pathological fractures excluded）
* Patients without heart and pulmonary dysfunction ≤class I

Exclusion Criteria:

* peripheral neuropathy of grade 2 or higher according to NCI-CTCAE Version 3.0
* Relapse and refractory MM
* MM without symptom
* Non-secretory MM without measurable diseases
* Karnofsky Performance Status\<50%（pathological fractures excluded）
* Patients with heart and pulmonary dysfunction\> class I

Primary outcomes:
measure: the rate of complete remission
timeFrame: Day 1 of every treatment cycle
Secondary outcomes:
measure: progression free survival
timeFrame: up to two year
measure: Adverse Events
timeFrame: up to two years
measure: overall response rates (ORR)
timeFrame: Day 1 of every treatment cycle
measure: duration of response
timeFrame: up to 6 months
measure: overall survival (OS)
timeFrame: up to two year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: zhai yo ping, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li F, Yao FS, Zhu XJ, Gu WY, Wang XH, Chen B, Huang DP, Ding JH, Wu TQ, Zhu Y, Zhao Q, Tang YM, Song P, Zhou XG, An ZM, Guo X, Wang XL, Zhong L, Xie XB, Zhai YP. A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients. J Cancer Res Clin Oncol. 2019 Sep;145(9):2343-2355. doi: 10.1007/s00432-019-02967-3. Epub 2019 Jul 6.