Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.

Multiple Myeloma Clinical Trial

Official title:

Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086942
• Other study ID #: NAB20130806
• Status: Recruiting
• Phase: Phase 2
• First received: March 12, 2014
• Last updated: August 27, 2017
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Jinling Hospital, China
• Contact: zhai yo ping, doctor
• Phone: 13951947646
• Email: zhaiyongping66[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
Induction therapy:1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,4 cycle Intensive therapy:1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,5 cycles.
• cyclophosphamide
Induction therapy:300mg/m2 VD Days 1-3 of each 28 day cycles,4 cycles. Intensive therapy:300mg/m2 VD Days 1-3 of each 28 day cycles,5 cycles. Maintenance treatment with CP: 200mg PO Days 1-14 of each 28 day cycles,12 cycles.
• Dexamethasone
Induction therapy:40 mg/d VD Days 1,6,11,16 of each 28 day cycles,4 cycles Intensive therapy:40 mg/d VD Days 1,6,11,16 of each 28 day cycles,5 cycles.

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yongping Zhai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of complete remission	The rate of complete remission of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.	Day 1 of every treatment cycle
Secondary	progression free survival	PFS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.	up to two year
Secondary	Adverse Events	Adverse events (AEs) were graded according to NCI-CTCAE Version 4.0	up to two years
Secondary	overall response rates (ORR)	The rate of overall response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.	Day 1 of every treatment cycle
Secondary	duration of response	Duration of response of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.	up to 6 months
Secondary	overall survival (OS)	The rate of OS of modified VCD regimens in patients with MM assessed by International Myeloma Working Group(IMWG) criteria.	up to two year