Two Cycles of PAD Combination by AHCT in MM - Full Text View

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: PAD combination	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Vincristine sulfate Dexamethasone sodium phosphate Doxorubicin Doxorubicin hydrochloride Bortezomib

U.S. FDA Resources

Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:

response rates and toxicities. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
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:

hematologic recovery [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
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

Enrollment:	43
Study Start Date:	July 2006
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370434

Locations

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

Investigators

Principal Investigator:

Jung-Hee Lee, professor

Asan Medical Center

More Information

Additional Information:

Two Cycles of PAD Combination by AHCT in MM (PADinMM) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AMC, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01370434 History of Changes
Other Study ID Numbers:	H-34
Study First Received:	May 16, 2011
Last Updated:	June 9, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:

MM

Additional relevant MeSH terms:

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 acetate

Dexamethasone
Dexamethasone 21-phosphate
Doxorubicin
Vincristine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 16, 2013