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Autologous Transplantation for Multiple Myeloma

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Autologous Transplantation for Multiple Myeloma

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check
the subject's general health. Subjects will have the following tests and evaluations to
find out if they can participate:--Medical history and physical examination, including
height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest
x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test
(PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will
have a serum pregnancy test performed. After eligible patients have been completely staged
and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and
Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for
collection. All patients will receive high-dose melphalan followed by an autologous stem
cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's
response to treatment and possible side effects of treatment. If necessary, platelet and
red cell transfusions will be given to maintain adequate levels and antibiotics will be
given to treat or prevent infection. Subjects may also require intravenous nutritional
support and pain medications during or after transplantation. The study coordinators will
collect health information over three years. They will collect information every week for
100 days, then at 6 months, 1 year, 2 years, and 3 years.

Inclusion Criteria:

- Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple
myeloma, requiring therapy and meeting one of the following:

- After initial therapy in either first complete or partial remission or no
objective response

- After achieving initial response and later disease progression, patient will be
eligible after subsequent therapy upon achievement of either complete or partial

- Is not eligible or has refused any protocols of higher priority

- 18 - 75 years of age

- Adequate organ function defined as:

- Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥
3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl

- Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA

- Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal

- Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity
(FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) >
50% predicted

- Performance status: Karnofsky performance of > 80%.

- Free of active uncontrolled infection at the time of study entry.

- At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and >
6 weeks from prior nitrosoureas.

- Patients must exercise informed voluntary consent and sign a consent form approved by
the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria:

- Patients will be ineligible if they have advanced myeloma refractory and unresponsive
to salvage chemotherapy regimens.

- Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded
from study entry. In addition fertile men or women unwilling to use contraceptive
techniques during and for 12 months following treatment, particularly after
thalidomide will also be excluded from study entry.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of Percentage of Patients Achieving a Complete Response

Outcome Description:

Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: Normal free light chain ratio Absence of clonal cells in bone marrow Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas.

Outcome Time Frame:

100 Days, 6 Months, 1 Year Post Treatment

Safety Issue:


Principal Investigator

Brian McClune, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Institutional Review Board

Study ID:




Start Date:

January 2004

Completion Date:

December 2015

Related Keywords:

  • Multiple Myeloma
  • stem cell transplantation
  • chemotherapy
  • multiple myeloma
  • autologous
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455