Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Etoposide

Cytarabine

Cyclophosphamide

Dexamethasone

Vincristine

Melphalan

Cisplatin

Dexamethasone acetate

Etoposide phosphate

Interferons

Interferon-alpha

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.

3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20

Approximately 5-6 weeks after VAD 2 or 3:

Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1

High-Dose cyclophosphamide

Hemopoietic stem cell procurement

Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5

EDAP

4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2

Autologous Hemopoietic Stem Cell Transplant 1

4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2

Autologous Hemopoietic Stem Cell Transplant 2

3 months after Transplant 2: Intron A 3 X 10\^6 units /m2 M-W-F subcutaneously until relapse

Maintenance

Bart Barlogie, MD, PhD

This experimental study evaluates the effects of a series of intensive drug regimens as initial treatment for Multiple Myeloma followed by 2 bone marrow transplantations 4-6 months apart in support of high-dose Melphalan, followed by Interferon treatment indefinitely.

UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma

Phase II Study of Intensive "TOTAL THERAPY" for Untreated or Minimally Treated Patients With Multiple Myeloma

Relapse is defined by the unequivocal objective evidence of recurrent disease such as:

myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis \>10% or \>5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for \>2 months.

University of Arkansas

Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.

VAD: 3 Cycles (3rd cycle optional):

Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20

High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:

Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1

Hemopoietic stem cell procurement: Collection target = 10 x 10\^6 cells/kg

EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma	NCT00580372	Multiple Myelom...	VAD High-Dose cyclo... Hemopoietic ste... EDAP Autologous Hemo... Autologous Hemo... Maintenance	18 Years -	University of Arkansas
UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma	NCT00580372	Multiple Myelom...	VAD High-Dose cyclo... Hemopoietic ste... EDAP Autologous Hemo... Autologous Hemo... Maintenance	18 Years -	University of Arkansas

Spots Global Cancer Trial Database for hemopoietic stem cell procurement