A Multicenter, Double Arms, Prospective Phase 4 Study to Evaluating the Efficacy and Safety of Combination Therapy of PAD Versus VCD Treatment in Previously Untreated Subjects With Multiple Myeloma.
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, screening, treatment and follow-up.
详细描述
Screening
At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria.
Treatment
Eligible patients are randomly assigned to receive either treatment PAD or VCD. All eligible subjects will be evaluated after 4 cycles treatment. According to the assessment of researchers and the willingness of patients to decide whether to autologous stem-cell transplantation (ASCT). Suitable for transplant patients will accept hematopoietic stem cell transplantation. Not suitable for transplant patients will continue accept treatment for 8 cycles. The patients who accept more than 4 cycles treatment will receive efficacy evaluation.
Follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged <65 years.
- •Previously untreated subjects with multiple myeloma.
- •No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain natriuretic peptide (BNP) < 500).
- •Pulmonary infection (if any) must be controlled effectively.
- •Chronic viral hepatitis (if any) must be controlled effectively.(Subjects with HBs Ag positive need to monitor hepatitis B virus-DNA (HBV-DNA )quantitative test regularly）；
- •Liver function (aminotransferase, bilirubin）?2 x the upper limit of normal (ULN).
- •Expected lifetime More than 3 months.
- •Be able to read and sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
排除标准
- •Patients with relapsed multiple myeloma.
- •Need to change the program according to the researchers' evaluated patients with disease progression during treatment.
- •Had uncontrolled or severe cardiovascular disease. Had a myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
- •Has a history of allergic reaction to compounds containing boron or mannitol.
- •Severe neuropathy may affect the treatment, according to the researchers to determine.
- •According to the program or the investigator's judgment, the patient is suffering from a serious physical illness or mental illness may interfere with participation in this clinical study.
- •Concurrent treatment with another investigational agent.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
PAD Followed by ASCT
Drug: Bortezomib(1.3mg/m2, iv, on day 1, 4, 8, 11)
Drug: Epidoxorubicin(15 mg/m2, iv, on days 1-4)
Drug: Dexamethasone(40mg, orally, on days 1-4)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
Not suitable for transplant patients will continue accept treatment for 8 cycles.
干预措施: PAD (Drug)
PAD Followed by ASCT
Drug: Bortezomib(1.3mg/m2, iv, on day 1, 4, 8, 11)
Drug: Epidoxorubicin(15 mg/m2, iv, on days 1-4)
Drug: Dexamethasone(40mg, orally, on days 1-4)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
Not suitable for transplant patients will continue accept treatment for 8 cycles.
干预措施: ASCT (Other)
VCD Followed by ASCT
Drug: Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11)
Drug: Cyclophosphamide (200mg/m2, orally, on days 1-5)
Drug: Dexamethasone(40mg, orally, on days 1-4)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
Not suitable for transplant patients will continue accept treatment for 8 cycles.
干预措施: VCD (Drug)
VCD Followed by ASCT
Drug: Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11)
Drug: Cyclophosphamide (200mg/m2, orally, on days 1-5)
Drug: Dexamethasone(40mg, orally, on days 1-4)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
Not suitable for transplant patients will continue accept treatment for 8 cycles.
干预措施: ASCT (Other)
结局指标
主要结局
Complete Response Rate
时间窗: Up to cycle 4 (with 28 days per cycle).
次要结局
- Safety(At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.)
- Overall Response Rate(At baseline, on day 28 of each cycle for 4 cycles.)
- Time To Response(At baseline, on day 28 of each cycle for 4 cycles.)
- 1-year Survival Rate(At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.)
- Overall Survival(At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.)
研究者
Jin Lu
Associate Chief Physician
Peking University People's Hospital