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Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma (Mel-Vel)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bortezomib 1 mg/m2
Bortezomib 1.3 mg/m2
Bortezomib 1.6 mg/m2
Melphalan
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A confirmed diagnosis of multiple myeloma

  2. Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan

    • May have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
  3. Age:18yrs-76yrs at time of melphalan administration
  4. Gender: There is no gender restriction

  5. Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation

    • Syngeneic transplantation is preferred
    • For patients enrolled in the phase I part of this study, >1x10^6 autologous or syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in case of engraftment failure
  6. Recovery from complications of salvage therapy, if administered -

Exclusion Criteria:

  1. Diagnosis other than multiple myeloma
  2. Chemotherapy or radiotherapy within 28 days of initiating treatment in this study
  3. Prior dose-intense therapy within 56 days of initiating treatment in this study
  4. Uncontrolled bacterial,viral,fungal or parasitic infections
  5. Uncontrolled CNS metastases
  6. Known amyloid deposition in heart

  7. Organ dysfunction

    • LVEF<40% or cardiac failure not responsive to therapy
    • FVC,FEV1,or DLCO<50% of predicted and/or receiving supplementary continuous oxygen
    • Evidence of hepatic synthetic dysfunction, or total bilirubin>2x or AST>3x ULN
    • Measured creatinine clearance <20ml/min
    • Sensory peripheral neuropathy grade 4
  8. Karnofsky score<70% unless a result of bone disease directly caused by myeloma
  9. Life expectancy limited by another co-morbid illness
  10. History of another malignancy in remission <2yrs (other than basal cell carcinoma)
  11. Pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
  12. Documented hypersensitivity to melphalan or bortezomib or any components of the formulation
  13. Patients unable or unwilling to provide consent

Sites / Locations

  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase I Cohort - Bortezomib 1 mg/m2

Phase I Cohort - Bortezomib 1.3 mg/m2

Phase I Cohort - Bortezomib 1.6 mg/m2

Phase II Cohort

Arm Description

Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.

Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.

Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.

Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.

Outcomes

Primary Outcome Measures

The Maximum Tolerated Dose of Bortezomib (MTD)
The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT

Secondary Outcome Measures

Full Information

First Posted
October 31, 2008
Last Updated
July 15, 2022
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT00784823
Brief Title
Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma
Acronym
Mel-Vel
Official Title
A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.
Detailed Description
Multiple myeloma is the second most common hematological malignancy that has affected approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of this disease but studies have reported improved response rates for patients who are treated with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase I/II study will investigate the potential of combination therapy of dose-intense melphalan with escalating doses of bortezomib.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
3 + 3 Dose Escalation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I Cohort - Bortezomib 1 mg/m2
Arm Type
Experimental
Arm Description
Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Arm Title
Phase I Cohort - Bortezomib 1.3 mg/m2
Arm Type
Experimental
Arm Description
Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Arm Title
Phase I Cohort - Bortezomib 1.6 mg/m2
Arm Type
Experimental
Arm Description
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Arm Title
Phase II Cohort
Arm Type
Experimental
Arm Description
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
Intervention Type
Drug
Intervention Name(s)
Bortezomib 1 mg/m2
Other Intervention Name(s)
Velcade
Intervention Description
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
Intervention Type
Drug
Intervention Name(s)
Bortezomib 1.3 mg/m2
Other Intervention Name(s)
Velcade
Intervention Description
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
Intervention Type
Drug
Intervention Name(s)
Bortezomib 1.6 mg/m2
Other Intervention Name(s)
Velcade
Intervention Description
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran
Intervention Description
Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period Melphalan will be given as a single dose (not split over 2 or more days) Dosing will be based body surface area calculated using actual body weight
Primary Outcome Measure Information:
Title
The Maximum Tolerated Dose of Bortezomib (MTD)
Description
The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT
Time Frame
During dosing of Bortezomib on Day -4 to Day -1 of ASCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A confirmed diagnosis of multiple myeloma Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan May have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol Age:18yrs-76yrs at time of melphalan administration Gender: There is no gender restriction Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation Syngeneic transplantation is preferred For patients enrolled in the phase I part of this study, >1x10^6 autologous or syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in case of engraftment failure Recovery from complications of salvage therapy, if administered - Exclusion Criteria: Diagnosis other than multiple myeloma Chemotherapy or radiotherapy within 28 days of initiating treatment in this study Prior dose-intense therapy within 56 days of initiating treatment in this study Uncontrolled bacterial,viral,fungal or parasitic infections Uncontrolled CNS metastases Known amyloid deposition in heart Organ dysfunction LVEF<40% or cardiac failure not responsive to therapy FVC,FEV1,or DLCO<50% of predicted and/or receiving supplementary continuous oxygen Evidence of hepatic synthetic dysfunction, or total bilirubin>2x or AST>3x ULN Measured creatinine clearance <20ml/min Sensory peripheral neuropathy grade 4 Karnofsky score<70% unless a result of bone disease directly caused by myeloma Life expectancy limited by another co-morbid illness History of another malignancy in remission <2yrs (other than basal cell carcinoma) Pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment Documented hypersensitivity to melphalan or bortezomib or any components of the formulation Patients unable or unwilling to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Rowley, MD
Organizational Affiliation
Director-Blood and Marrow Transplantation Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

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Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma

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