A Phase 2 interventional study of Fludarabine/Busulfan x 4 days and stem cell transplant in Multiple Myeloma and Plasma Cell Leukemia, sponsored by University of Michigan Rogel Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-04.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.
This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.
3,632 studies on the registry are indexed under Multiple Myeloma; 744 are open to participants now.
This study's enrollment of 22 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →University of Michigan Rogel Cancer Center is the lead sponsor of 317 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Biologic high risk Multiple Myeloma:
Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics.
Exclusion Criteria:
Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.
Drug: Fludarabine/Busulfan x 4 days · Procedure: stem cell transplant
* Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. * Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
Allogeneic, peripheral blood stem cell transplant
The Percentage of Patients Alive 1 Year Post Transplant
The primary objective is overall survival, one year from the time of transplant.
Time frame: 1 Year
The Percentage of Patients Free From Progression at 1 Year
One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
Time frame: 1 Year
Percentage of Patients With Treatment Related Mortality (TRM)
Time frame: 100 days, one-year
Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus
Time frame: 100 days, 2 years
Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
Time frame: 3 years
| Milestone | Flu-Bu4 |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
The primary objective is overall survival, one year from the time of transplant.
| percentage of patients | Flu-Bu4 |
|---|---|
| The Percentage of Patients Alive 1 Year Post Transplant | 61 (43 to 87) |
One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
| percentage of patients | Flu-Bu4 |
|---|---|
| The Percentage of Patients Free From Progression at 1 Year | 40 (23 to 67) |
| percentage of patients | Flu-Bu4 |
|---|---|
| Percentage of Patients With Treatment Related Mortality (TRM) | 9 (2 to 33) |
Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus
| percentage of participants | Flu-Bu4 |
|---|---|
| Grade II-IV Acute GVHD | 48 (29 to 72) |
| Grade III-IV Acute GVHD | 23 (10 to 47) |
| Chronic GVHD | 55 (34 to 78) |
Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
| percentage of deaths | Flu-Bu4 |
|---|---|
| NRM at 1 Year | 19 (7 to 44) |
| NRM at 3 Years | 29 (13 to 55) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flu-Bu4 | — | 13/22 (59.1%) | 20/22 (90.9%) |
| Event | Flu-Bu4 |
|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 3/22 |
| Blood/Bone Marrow - OtherBlood and lymphatic system disorders | 2/22 |
| HypotensionCardiac disorders | 2/22 |
| FeverGeneral disorders | 2/22 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 2/22 |
| DiarrheaGastrointestinal disorders | 2/22 |
| Renal failureRenal and urinary disorders | 2/22 |
| Allergy/Immunology - OtherImmune system disorders | 1/22 |
| Cardiac General - OtherCardiac disorders | 1/22 |
| Death, disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/22 |
| Event | Flu-Bu4 |
|---|---|
| Sinus tachycardiaCardiac disorders | 8/22 |
| TremorNervous system disorders | 7/22 |
| HypotensionCardiac disorders | 6/22 |
| Dermatology/Skin - OtherSkin and subcutaneous tissue disorders | 6/22 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 6/22 |
| Taste alteration (dysgeusia)Gastrointestinal disorders | 6/22 |
| DizzinessNervous system disorders | 6/22 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 5/22 |
| Infection - Other (Specify)Infections and infestations | 5/22 |
| Edema: limbGeneral disorders | 5/22 |
| Age, Continuous(years) | Flu-Bu4 |
|---|---|
| Median | 54 (45 to 70) |
| Sex: Female, Male(Participants) | Flu-Bu4 |
|---|---|
| Female | 8 |
| Male | 14 |
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center