Overview

Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
This phase I/II trial studies the safety and best dose of melphalan and bortezomib when given prior to an autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may help melphalan work better by making cancer cells more sensitive to the drug. Giving chemotherapy before an autologous hematopoietic stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving melphalan together with bortezomib prior to autologous hematopoietic stem cell transplant may be a better treatment for multiple myeloma.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Colorado, Denver
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Melphalan
Criteria
Inclusion Criteria:

- Patients with symptomatic active multiple myeloma requiring treatment, including those
whose prior smoldering myeloma progressed to symptomatic disease requiring
chemotherapy; both newly diagnosed and previously treated patients are eligible for
the study

- Presence of quantifiable M-component of immunoglobulin G (IgG), IgA, IgD, or IgE
and/or urinary kappa or lambda light chain or Bence Jones protein, in order to
evaluate response; non-secretory patients are eligible provided the patient has > 20%
plasmacytosis or multiple (> 3) focal plasmacytomas on magnetic resonance imaging
(MRI) or diffuse hyperintense signal on short tau inversion recovery (STIR) weighted
images

- Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients
with a poor performance status (3-4) are also eligible after having improved their
performance to 0-2

- No significant co-morbid medical conditions; no uncontrolled life threatening
infection

- Patient evaluation should be done within 35 days prior to registration; signed
informed consent should be obtained from all patients in accordance with institutional
and federal guidelines

Exclusion Criteria:

- Patients with a history of recent (< 6 months) myocardial infarction, unstable angina,
difficult to control congestive heart failure, uncontrolled hypertension, difficult to
control significant cardiac arrhythmias, or arrhythmia associated with prolonged QT
interval; left ventricular ejection fraction by echocardiogram or multi gated
acquisition scan (MUGA) < 45% assessed within 35 days prior to study registration

- Patients with a history of moderate to severe chronic obstructive and/or restrictive
pulmonary disease, with a forced expiratory volume in 1 second (FEV1) or forced vital
capacity (FVC) < 50% of the predicted values; diffusing capacity of the lung for
carbon monoxide (DLCO) < 50%; partial pressure of oxygen (P02) < 70 mmHg

- Patients with a prior history of malignancy except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient has been disease free for at least three years

- Pregnant or nursing women; women of child-bearing potential must have a negative
pregnancy documented within one week of registration; women/men of reproductive
potential may not participate unless they have agreed to use two forms of effective
contraceptive method

- Human immunodeficiency virus (HIV) positive patients

- Transaminases > 2 x normal values or bilirubin > 2 x normal values; prior history of
chronic liver disease

- Patients with renal failure on dialysis

- Active uncontrolled infection

- History of significant psychiatric illness