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Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

Primary Purpose

Multiple Myeloma, Plasma Cell Leukemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fludarabine/Busulfan x 4 days

stem cell transplant

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Stage II/III Multiple Myeloma(within 10 months from diagnosis), high risk, relapse, persistent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
  - Relapsed or persistent multiple myeloma after ASCT.
  - Persistent multiple myeloma, regardless of previous therapies.
  - Plasma cell leukemia, regardless of previous therapies.
Age up to 70 years old (less than 71 years old at the date of transplant admission).
Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)

Exclusion Criteria:

Persistent invasive infections, not controlled by antimicrobials.
HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity.
Uncontrolled medical or psychiatric disorder.
No response or progressive disease at the time of transplantation.
Pregnancy

Sites / Locations

University of Michigan,Department of Internal Med. Hematology- Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flu-Bu4

Arm Description

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Outcomes

Primary Outcome Measures

The Percentage of Patients Alive 1 Year Post Transplant

The primary objective is overall survival, one year from the time of transplant.

Secondary Outcome Measures

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.

Percentage of Patients With Treatment Related Mortality (TRM)

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

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.

Full Information

NCT ID

NCT00615589

First Posted

January 22, 2008

Last Updated

March 3, 2016

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00615589

Brief Title

Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

Official Title

Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

Low accrual

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Plasma Cell Leukemia

Keywords

Stage II/III Multiple Myeloma(within 10 months from diagnosis), high risk, relapse, persistent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flu-Bu4

Arm Type

Experimental

Arm Description

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Intervention Type

Drug

Intervention Name(s)

Fludarabine/Busulfan x 4 days

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

stem cell transplant

Intervention Description

Allogeneic, peripheral blood stem cell transplant

Primary Outcome Measure Information:

Title

The Percentage of Patients Alive 1 Year Post Transplant

Description

The primary objective is overall survival, one year from the time of transplant.

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

The Percentage of Patients Free From Progression at 1 Year

Description

Time Frame

1 Year

Title

Percentage of Patients With Treatment Related Mortality (TRM)

Time Frame

100 days, one-year

Title

Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)

Description

Time Frame

100 days, 2 years

Title

Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Relapsed or persistent multiple myeloma after ASCT. Persistent multiple myeloma, regardless of previous therapies. Plasma cell leukemia, regardless of previous therapies. Age up to 70 years old (less than 71 years old at the date of transplant admission). Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant. Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission) Exclusion Criteria: Persistent invasive infections, not controlled by antimicrobials. HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity. Uncontrolled medical or psychiatric disorder. No response or progressive disease at the time of transplantation. Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Attaphol Pawarode, MD

Organizational Affiliation

University of Michigan Dept. of Internal Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan,Department of Internal Med. Hematology- Oncology

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

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