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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAD Followed by ASCT | Experimental | 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. |
|
| VCD Followed by ASCT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAD | Drug | Induction Therapy of PAD for 4 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Up to cycle 4 (with 28 days per cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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. | At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up. |
| Overall Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Lu, PhD | Contact | onco_velcade123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Lu, PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital, Institute of Hematology, Peking University | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| VCD | Drug | Induction Therapy of VCD for 4 cycles. |
|
|
| ASCT | Other | Not suitable for transplant patients will continue accept treatment for 8 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. |
| 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. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |