Clinical trial NCT00177047: Autologous Transplant for Multiple Myeloma
Official title: Autologous Transplantation for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Keywords: stem cell transplantation
chemotherapy
multiple myeloma
autologous
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

Detailed description: 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.

Eligibility criteria: 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 response
* 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 (untransfused)
  * Cardiac: no active ischemia, left ventricular ejection fraction \> 45% by MUGA scan
  * 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.

Primary outcomes:
measure: Number of Participants Achieving a Complete Response
timeFrame: 100 Days post transplant
measure: Number of Participants Achieving a Complete Response
timeFrame: 6 months post transplant
measure: Number of Participants Achieving a Complete Response
timeFrame: 12 months post transplant
Secondary outcomes:
measure: Number of Patients With Extended Disease-free Survival
timeFrame: 36 Months
measure: Number of Participants With Overall Survival
timeFrame: 1 year
measure: Number of Participants With Overall Survival
timeFrame: 2 years
measure: Number of Participants With Overall Survival
timeFrame: 3 years
measure: Count of Participants Experiencing Transplant Related Mortality
timeFrame: 1 year
measure: Number of Participants Experiencing Incidence of Relapse
timeFrame: 1 year
measure: Number of Participants With Disease Progression
timeFrame: 1 year
measure: Time to Progression
timeFrame: 1 year
measure: Time to Relapse
timeFrame: 1 year
measure: Number of Participants With Absolute Neutrophil Recovery
timeFrame: Day 42
measure: Time to Attainment of CR
timeFrame: 12 months post transplant
measure: Time to Attainment of CR+PR
timeFrame: 12 months post transplant
measure: Duration of Maintenance Treatment
timeFrame: During study
measure: Dropout Rate From Maintenance Therapy
timeFrame: Post transplant phase
measure: Number of Participants With Toxicities
timeFrame: By first 100 days
measure: Number of Participants With Infections
timeFrame: By first 100 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Claudio Brunstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: