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A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01868828
Recruitment Status : Unknown
Verified June 2013 by Jin Lu, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : June 5, 2013
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
Jin Lu, Peking University People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PAD Drug: VCD Other: ASCT Phase 4

Detailed Description:

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: 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.

Drug: PAD
Induction Therapy of PAD for 4 cycles.
Other Name: Induction Therapy

Other: ASCT
Not suitable for transplant patients will continue accept treatment for 8 cycles.

Experimental: 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.

Drug: VCD
Induction Therapy of VCD for 4 cycles.
Other Name: Induction Therapy

Other: ASCT
Not suitable for transplant patients will continue accept treatment for 8 cycles.




Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: Up to cycle 4 (with 28 days per cycle). ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up. ]
    Safety evaluations will be based on scheduled clinical laboratory tests, electrocardiogram or cardiac ultrasonography (when appropriate), vital signs, physical examination and number of adverse events.

  2. Overall Response Rate [ Time Frame: At baseline, on day 28 of each cycle for 4 cycles. ]
    Overall response rate included Complete Response (CR), Very good partial response (VGPR) and PR, before the new treatment, two consecutive evaluations are in line with defined criteria in order to confirm the efficacy evaluation.

  3. Time To Response [ Time Frame: At baseline, on day 28 of each cycle for 4 cycles. ]
  4. 1-year Survival Rate [ Time Frame: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up. ]
  5. Overall Survival [ Time Frame: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 regularly);
  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 amyloidosis.
  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 determine.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868828


Contacts
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Contact: Jin Lu, PhD onco_velcade123@163.com

Locations
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China, Beijing
Peking University People's Hospital, Institute of Hematology, Peking University Recruiting
Beijing, Beijing, China, 100044
Contact: Jin Lu, PhD       onco_velcade123@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Jin Lu, PhD Peking University People's Hospital

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Responsible Party: Jin Lu, Associate Chief Physician, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01868828     History of Changes
Other Study ID Numbers: PAD VS VCD Clinical Protocol
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013
Keywords provided by Jin Lu, Peking University People's Hospital:
Multiple Myeloma
Combination Therapy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors