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A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma (BMT CTN #0102)

Phase 3
70 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma (BMT CTN #0102)

Multiple myeloma (MM), characterized by malignant plasma cell proliferation, bone
destruction, and immunodeficiency, is a disease with a median age at diagnosis of
approximately 65 years. It is responsible for about 1 percent of all cancer-related deaths
in Western Countries. Conventional treatments with chemotherapy and radiation therapy are
non-curative but improve quality of life and duration of survival. Attempts to cure myeloma
through high-dose therapy followed by autografting or allografting have largely failed due
to a combination of relapsed disease or transplant related mortality (TRM). High-dose
therapy with autologous transplantation is safe and has low TRM (less than 5%), but is
associated with a continuing and nearly universal risk of disease progression and relapse.
Even so, autologous transplantation is superior to continued conventional chemotherapy.
Recent data indicate that tandem autologous transplants are superior to a single procedure.
Even with this approach, patients remain at risk of relapse and additional approaches are


The overall study design is that of biologic assignment, based on the availability of an
HLA-matched sibling, to one of two treatment strategies for MM patients. Patients without
an HLA-matched sibling will undergo tandem autologous transplants. Patients with an
HLA-matched sibling will undergo an autologous transplant followed by a non-myeloablative
allogeneic transplant. In addition, the tandem autologous transplant recipients will be
randomized to either observation or one year of maintenance therapy to begin following the
second autologous transplant. The large number of MM patients without an HLA-matched
sibling enables us to evaluate the role of maintenance therapy following tandem autologous

Inclusion Criteria:

- Meeting the Durie and Salmon criteria for initial diagnosis of MM

- Stage II or III MM at diagnosis or anytime thereafter

- Symptomatic MM requiring treatment at diagnosis or anytime thereafter

- Received at least three cycles of initial systemic therapy and are within 2-10 months
of initiation of the initial therapy (this time frame excludes the time for
mobilization therapy)

- If receiving chemotherapy-based mobilization regimens, must be able to receive
high-dose melphalan between 2 and 8 weeks after the initiation of mobilization
therapy whether delivered at the transplant center or at a referring center

- Adequate organ function as measured by:

1. Cardiac: Left ventricular ejection fraction at rest greater than 40%

2. Hepatic: Bilirubin less than 2 times the upper limit of normal and ALT and AST
less than 3 times the upper limit of normal

3. Renal: Creatinine clearance greater than 40 ml/min (measured or

4. Pulmonary: DLCO, FEV1, and FVC greater than 50% of predicted value (corrected
for hemoglobin), or O2 saturation greater than 92% of room air

- An adequate autologous graft defined as a cryopreserved PBSC graft containing at
least 4.0 x 106 CD34+ cells/kg patient weight; if prior to enrollment it is known
that a patient will be on the auto-allo arm (i.e., a consenting, eligible HLA-matched
sibling donor is available), the required autograft must contain at least 2.0 x 10^6
CD34+ cells/kg patient weight; the graft may not be CD34+ selected or otherwise
manipulated to remove tumor or other cells; the graft can be collected at the
transplanting institution or by a referring center; for patients without an
HLA-matched sibling donor, the autograft must be stored so that there are two
products each containing at least 2 x 10^6 CD34+ cells/kg patient weight

Exclusion Criteria:

- Never advanced beyond Stage I MM since diagnosis

- Non-secretory MM (absence of a monoclonal protein [M protein] in serum as measured by
electrophoresis and immunofixation and the absence of Bence Jones protein in the
urine defined by use of conventional electrophoresis and immunofixation techniques)

- Plasma cell leukemia

- Karnofsky performance score less than 70%, unless approved by the Medical Monitor or
one of the Protocol Chairs

- Uncontrolled hypertension

- Uncontrolled bacterial, viral, or fungal infections (currently taking medication and
progression of clinical symptoms)

- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma
in situ; cancer treated with curative intent less than 5 years previously will not be
allowed unless approved by the Medical Monitor or one of the Protocol Chairs; cancer
treated with curative intent more than 5 years previously will be allowed

- Pregnant or breastfeeding

- Seropositive for the human immunodeficiency virus (HIV)

- Unwilling to use contraceptive techniques during and for 12 months following

- Prior allograft or prior autograft

- Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy

- Prior organ transplant requiring immunosuppressive therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Three-year progression-free survival

Outcome Time Frame:

Measured at 3 years

Safety Issue:


Principal Investigator

David G. Maloney, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

March 2014

Related Keywords:

  • Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Refractory Plasma Cell Neoplasm
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Cleveland Clinic Foundation Cleveland, Ohio  44195
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Medical College of Wisconsin Milwaukee, Wisconsin  53226
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Hackensack University Medical Center Hackensack, New Jersey  07601
Tufts - New England Medical Center Boston, Massachusetts  02111
City of Hope National Medical Center Los Angeles, California  91010
Baylor University Medical Center Dallas, Texas  75246
University of Minnesota Minneapolis, Minnesota  55455
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Vanderbilt University Nashville, Tennessee  37232-6305
Duke University Medical Center Durham, North Carolina  27710
University of Michigan Medical Center Ann Arbor, Michigan  48104-0914
University of Texas Southwestern Medical Center Dallas, Texas  
Wichita CCOP Wichita, Kansas  67214-3882
Texas Transplant Institute San Antonio, Texas  78229
Kansas City Cancer Centers - Central Kansas City, Missouri  64111
DeKalb Medical Center Decatur, Georgia  30033
Loyola University Maywood, Illinois  60153
UCSD Medical Center La Jolla, California  92093
Stanford Hospital and Clinics Stanford, California  94305
University of Florida College of Medicine (Shands) Gainesville, Florida  32610
Washington University/Barnes Jewish Hospital St. Louis, Missouri  63110
University Hospitals of Cleveland/Case Western Cleveland, Ohio  44106
Indiana BMT at Beech Grove Beech Grove, Indiana  46107
DFCI/Brigham & Women's Boston, Massachusetts  02114
University of Oklahoma Medical Center Oklahoma City, Oklahoma  73104
Baylor College of Medicine/The Methodist Hospital Houston, Texas  77030-2399
Virginia Commonwealth University MCV Hospitals Richmond, Virginia  23298-0037
City of Hope Samaritan Phoenix, Arizona  85006
Scripps Clinic/Green Hospital La Jolla, California  92037-1027
Rocky Mountain BMT Denver, Colorado  80218
BMT Group of Georgia/Northside Hospital Atlanta, Georgia  30342
Oregon Health Sciences University (A) Portland, Oregon  97239-3098
Fox Chase - Temple University - BMT Program Philadelphia, Pennsylvania  19111-2442
University of Texas/MD Anderson Cancer Research Center Houston, Texas  77030
University of Wisconsin Hospitals & Clinics Madison, Wisconsin  53792-6164