Two Cycles of PAD Combination by AHCT in MM (PADinMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370434
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Information provided by:
Cooperative Study Group A for Hematology

Brief Summary:
Based the proven efficacy and the ability to induce rapid response of various combinations of bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PAD combination Phase 2

Detailed Description:

1.PAD combination chemotherapy

  • Bortezomib 1.3 mg/m2 will be given by intravenous bolus injection on days 1, 4, 8, 11 of each cycle. Oral or intravenous dexamethasone 40 mg will be administered on days 1-4 and 8-11 with doxorubicin 9 mg/m2 by intravenous bolus on days 1-4 of each cycle. The cycle will be repeated every 3 weeks. A total of 2 cycles is planed before AHCT.
  • For mobilization, G-CSF 10ug/kg/d alone will be given by subcutaneous injection from day 12 of the second PAD cycle until completion of harvesting.

Melphalan 100 mg/m2/day will be administered on day -3 and day -2 for high-dose chemotherapy.

-Maintenance :Thalidomide 100 - 200 mg/d for 2 years

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
Study Start Date : July 2006
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: VAD combination
  • vincristine 0.4mg iv on D1-4
  • doxorubicin 9mg/m2 iv on D1-4
  • dexamethasone 40mg/d po on D1-4,9-12,17-20
  • Many physicians use vincristine, doxorubicin, and dexamethasone (VAD) for three to four months as induction therapy (Alexandrian et al, 1990). VAD produces partial response (PR) in about 50% patients, with complete response (CR) observed in 5%-10% patients (Kyle et al, 2004).
Drug: PAD combination
  • Bortezomib 1.3 mg/m2/d iv on D 1, 4, 8, 11
  • Doxorubicin 9 mg/m2/d iv on D 1-4
  • Dexamethasone 40mg/d po or iv on D1-4, 8-11
Other Names:
  • -vincristine
  • -doxorubicin
  • -dexamethasone

Primary Outcome Measures :
  1. response rates and toxicities. [ Time Frame: 2.5 years ]
    To investigate the effectiveness of bortezomib, doxorubicin and dexamethasone (PAD) combination therapy in the treatment of previously untreated patients with multiple myeloma who are eligible for autologous hematopoietic cell transplantation (AHCT). The effectiveness will be evaluated in terms of response, response rates, and toxicities.

Secondary Outcome Measures :
  1. hematologic recovery [ Time Frame: 2.5 years ]
    To evaluate the feasibility of harvesting peripheral blood stem cells (PBSC) and performing AHCT after 2 cycles of PAD in newly diagnosed MM. Cell counts of harvested PBSC and hematologic recovery after AHCT will be monitored

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with newly diagnosed symptomatic MM (see Appendix I)
  • Patients should be eligible for AHCT.
  • Patients should have measurable serum or urine paraprotein.
  • The performance status of the patients should be 70 or over by Karnofsky performance scale
  • Adequate hepatic and renal function: serum bilirubin < 1.5 x the upper limit of normal (ULN), serum alanine aminotransferase (ALT)/aspartate aminotransaminase (AST) values < 2.5 x ULN, serum creatinine < 1.5 x ULN
  • Adequate cardiac function: ejection fraction > 40% by echocardiogram or radionuclide heart scan

Exclusion Criteria:

  • prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or localized radiotherapy or plasmapheresis for the treatment of clinically significant hyperviscosity syndrome
  • have a peripheral neuropathy of grade 2 or more within 14 days of enrollment.
  • significant infection

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 identifier (NCT number): NCT01370434

Korea, Republic of
Asan Medical Center
Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Principal Investigator: Jung-Hee Lee, professor Asan Medical Center

Additional Information:
Responsible Party: AMC, Asan Medical Center Identifier: NCT01370434     History of Changes
Other Study ID Numbers: H-34
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Cooperative Study Group A for Hematology:

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists