High Dose Busulfan and Bortezomib in Treating Patients With High Risk Multiple Myeloma Undergoing Stem Cell Transplant

Stopped early · Phase 2

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

This pilot phase II trial studies how well giving high dose busulfan together with bortezomib works in treating patients with high risk multiple myeloma undergoing stem cell transplant. Drugs used in chemotherapy, such as busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cells growth. Giving busulfan together with bortezomib before a stem cell transplant may kill more cancer cells

Key facts

Study ID

NCT01534143

Run by

Barbara Ann Karmanos Cancer Institute

People needed

1

Starts

2012-02-01

Expected to finish

2013-05-01

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide informed consent
• Karnofsky Performance Status (KPS) >= 70
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Availability of a suitable allogeneic hematopoietic stem cell donor; minimum of human leukocyte antigen (HLA) 7/8 matched related or unrelated donor
• High risk multiple myeloma with poor prognostic features based on having one or more of the following criteria:
• Progressive disease after autologous transplant. No less than 3 months post auto transplant
• Progressive or stable disease after induction chemotherapy using the most potent myeloma agents Lenalidomide and/or Bortezomib
• Patients with high risk cytogenetic abnormalities documented on conventional cytogenetics or fluorescence in situ hybridization (FISH) (hypodiploidy, t(4:14), t(14:16) chromosome translocation, p53 and or complex cytogenetics) additionally, chromosome 13 deletion by standard cytogenetics
• Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test for women, as well as implementation of birth control for men and women

You may not qualify if…

• Patients with prior allogeneic transplant, or more than one prior autologous transplant for any medical reason
• Prior treatment with busulfan or gemtuzumab (Mylotarg ®) for any reason
• Patient with history of allergy to boron, mannitol, or bortezomib
• Creatinine clearance (CrCl) =< 50 ml/min
• Ejection Fraction < 50%
• Diffusion capacity of carbon monoxide (DLCO) < 50% predicted
• Forced expiratory volume in 1 second (FEV1) < 50% predicted
• Forced vital capacity (FVC) < 50% predicted
• Patients with uncontrolled arrhythmia or uncontrolled heart disease at the screening time; patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echo or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the principal investigator
• Liver enzymes > 3 times upper limit normal
• Bilirubin > 2 mg/dl (except Gilbert's disease)
• International normalized ratio (INR) > 2
• Any previous history of liver failure, hepatitis, or cirrhosis
• Systemic Amyloidosis Known history of hepatitis B, C, human immunodeficiency virus (HIV) or any current uncontrolled infection
• Grade > I neuropathy
• Women who are pregnant or lactating
• Current or history of alcohol or drug abuse
• Use of other investigational agents within 30 days of enrollment to this study
• Any patient with ascites
• Any patient on home oxygen
• Any clinical findings on history or physical exam which would in the opinion of the treating physician or principal investigator preclude the patient from participating in the study

Where it is running

• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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