Two Cycles of PAD Combination by AHCT in MM

NCT01370434 | Completed Phase 2 DMC

• 1 other identifier: H-34
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

MM

Outcome Measures

Primary Outcomes (1)

• response rates and toxicities.

  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.

  2.5 years

Secondary Outcomes (1)

• hematologic recovery

  2.5 years

Study Arms (1)

VAD combination

NO INTERVENTION

* 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

Interventions

PAD combination DRUG

* 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

Also known as: -vincristine, -doxorubicin, -dexamethasone

VAD combination

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736, South Korea

Location

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Vincristine; Doxorubicin; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Jung-Hee Lee, professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: June 10, 2011
• Study Start: July 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

KR (1)