NCT00941720

Brief Summary

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 2, 2014

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3.7 years

First QC Date

July 17, 2009

Results QC Date

February 13, 2014

Last Update Submit

July 22, 2020

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (2)

  • Relapse-free Survival

    Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .

    at 6 months

  • Overall Survival

    Number of patients alive at the end of the study period

    at 6 months

Secondary Outcomes (1)

  • Pulmonary Toxicity

    At 6 months

Study Arms (1)

Busulfan Treatment

EXPERIMENTAL
Drug: busulfanDrug: cyclophosphamideProcedure: autologous hematopoietic stem cell transplantation

Interventions

busulfanDRUG

IV busulfan 0.8 mg/kg every 6 hours x 16 doses

Also known as: BSF, BU, Misulfan, Mitosan, Myeloleukon, Myelosan
Busulfan Treatment
cyclophosphamideDRUG

IV cyclophosphamide 60 mg/kg over 4 hours x 2 days

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana, Enduxan
Busulfan Treatment
autologous hematopoietic stem cell transplantationPROCEDURE

infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0

Busulfan Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of plasma cell myeloma
  • Patients with cardiac ejection fraction \>= 45% or clearance by Cleveland Clinic Faculty (CCF) cardiologist
  • Patients with diffusion capacity of carbon monoxide (DLCO) \>= 45% predicted or clearance by CCF pulmonologist
  • Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10\^6 CD 34+ cells/kg harvested

You may not qualify if:

  • Patients receiving total body irradiation
  • Non-myeloablative/reduced-intensity conditioning
  • Pregnant and breast feeding patients
  • Human immunodeficiency virus (HIV) positive
  • Patients with serum creatinine \> 2.0
  • Prior Hematopoietic Stem Cell (HSC) transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

BusulfanCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Dr. Ronald Sobecks
Organization
CCCC
sobeckr@ccf.org
216-444-6833

Study Officials

  • Ronald M. Sobecks, MD

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 20, 2009

Study Start

June 11, 2009

Primary Completion

February 28, 2013

Study Completion

February 28, 2013

Last Updated

July 24, 2020

Results First Posted

April 2, 2014

Record last verified: 2020-07

Locations

US(1)