S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

This study has been withdrawn prior to enrollment.
(lack of accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01055301
First received: January 22, 2010
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Plasma Cell Myeloma
Drug: bortezomib
Drug: cisplatin
Drug: cyclophosphamide
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: lenalidomide
Drug: melphalan
Drug: thalidomide
Genetic: gene expression analysis
Genetic: microarray analysis
Other: laboratory biomarker analysis
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S0833, Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients With Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged ≤ 65 Years

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression-free survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Gene expression profiling analysis of CD138+ purified plasma cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment

Ind (1cycle):

bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d & dex 20mg/d PO; cisplatin & dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.

PBSC Coll: at recovery per local standard

Bridging (before/between trans/after Cons):

thal 50mg/d D1-21 & dex 20mg D1,8,15 PO

Tandem Trans (x2):

bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d & dex 40mg/d PO PBSC >/=200x10^6 cells

Cons (1cycle):

same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox

Maint(</= 3 yrs):

D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20

Drug: bortezomib
Other Name: bort
Drug: cisplatin Drug: cyclophosphamide Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: lenalidomide Drug: melphalan Drug: thalidomide Genetic: gene expression analysis Genetic: microarray analysis Other: laboratory biomarker analysis Procedure: autologous-autologous tandem hematopoietic stem cell transplantation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed active multiple myeloma (MM)
  • Measurable disease

    • Non-secretory disease allowed provided patient has ≥ 20% plasmacytosis or multiple (> 3) focal plasmacytomas on skeletal survey and/or MRI

PATIENT CHARACTERISTICS:

  • Zubrod performance status (PS) 0-2 (Zubrod PS 3-4 allowed if based solely on bone pain)
  • ANC ≥ 1,500/mm^3*
  • Platelet count ≥ 150,000/mm^3*
  • Serum creatinine clearance of ≥ 60 mL/min

    • Patients with creatinine clearance of < 60 mL/min receive a lower dose of melphalan
    • No patients receiving or planning to receive dialysis
  • Total bilirubin ≤ 1.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

    • Must be fully aware of the teratogenic potential of thalidomide
    • Must be willing to comply with the FDA-mandated S.T.E.P.S. program
  • Ejection fraction > 40% as measured by MUGA scan or two-dimensional ECHO
  • No peripheral neuropathy ≥ grade 2 per CTCAE v. 4.0
  • No known hypersensitivity to bortezomib, boron, or mannitol
  • No uncontrolled diabetes defined as fasting glucose level > 200 mg/dL on at least more than two occasions or more that two serum random blood levels > 300 mg/dL despite adequate treatment

    • Patients with a history of diabetes mellitus requiring treatment should be on a stable regimen and have their blood glucose closely monitored
  • No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment within the past year NOTE: *Unless myeloma-related marrow infiltration is documented, defined as ≥ 30% marrow cellularity with 50% of the cells being malignant plasma cells.

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior chemotherapy or radiotherapy
  • No more than 1 prior course of chemotherapy for MM

    • Prior chemotherapy must not have included melphalan
  • No prior radiotherapy to large area of the pelvis (more than half of the pelvis)
  • Prior radiotherapy for symptomatic localized bone lesions or impending cord compression allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055301

Locations
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
Hematology-Oncology Clinic
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Washington
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center Cancer Center
Burien, Washington, United States, 98166
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States, 98274
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States, 98370
Harborview Medical Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology, PS
Spokane, Washington, United States, 99218
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Muneer H. Abidi, MD Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01055301     History of Changes
Other Study ID Numbers: CDR0000663952, S0833, U10CA032102
Study First Received: January 22, 2010
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

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
Liposomal doxorubicin
Lenalidomide
Bortezomib
Cisplatin
Cyclophosphamide
Dexamethasone
Doxorubicin
Thalidomide
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014