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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.

Phase 4
65 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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.


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.


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


All patients will receive 12 months of follow-up after the treatment period. Follow-up at 4,
6, 8 and 12 month after the treatment period respectively. Subjects who have disease
progression or accept other resistance myeloma therapy during the 12 months of follow-up
phase will stop assessed about the study and start followed up only for survival status
every 6 months through telephone interviews or to research center follow-up. All patients
will accept the follow-up for survival until last case patient who complete follow-up.

Safety will be evaluated throughout the study by assessment of adverse events (AEs),
physical examination, vital signs and clinical laboratory findings.

Inclusion Criteria:

1. Men or women aged <65 years.

2. Previously untreated subjects with multiple myeloma.

3. No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain
natriuretic peptide (BNP) < 500).

4. Pulmonary infection (if any) must be controlled effectively.

5. 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

6. Liver function (aminotransferase, bilirubin)?2 x the upper limit of normal (ULN).

7. Expected lifetime More than 3 months.

8. 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.

Exclusion Criteria:

1. Patients with relapsed multiple myeloma.

2. Need to change the program according to the researchers' evaluated patients with
disease progression during treatment.

3. 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

4. Has a history of allergic reaction to compounds containing boron or mannitol.

5. Severe neuropathy may affect the treatment, according to the researchers to

6. 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.

7. Concurrent treatment with another investigational agent.

8. Pregnant or breast-feeding women.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response Rate

Outcome Time Frame:

Up to cycle 4 (with 28 days per cycle).

Safety Issue:


Principal Investigator

Jin Lu, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University People's Hospital


China: Food and Drug Administration

Study ID:

PAD VS VCD Clinical Protocol



Start Date:

May 2013

Completion Date:

May 2017

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Combination Therapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell