NCT00784823 · REGISTRY CONDITION SEARCH

Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2022-08-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

The Maximum Tolerated Dose of Bortezomib (MTD)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 76 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
intervention Names
Drug: Bortezomib 1 mg/m2
Drug: Melphalan
label
Phase I Cohort - Bortezomib 1 mg/m2
type
EXPERIMENTAL
description
Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
intervention Names
Drug: Bortezomib 1.3 mg/m2
Drug: Melphalan
label
Phase I Cohort - Bortezomib 1.3 mg/m2
type
EXPERIMENTAL
description
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
intervention Names
Drug: Bortezomib 1.6 mg/m2
Drug: Melphalan
label
Phase I Cohort - Bortezomib 1.6 mg/m2
type
EXPERIMENTAL
description
Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
intervention Names
Drug: Bortezomib 1.6 mg/m2
Drug: Melphalan
label
Phase II Cohort
type
EXPERIMENTAL

interventions

arm Group Labels
Phase I Cohort - Bortezomib 1 mg/m2
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
name
Bortezomib 1 mg/m2
other Names
Velcade
type
DRUG
arm Group Labels
Phase I Cohort - Bortezomib 1.3 mg/m2
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
name
Bortezomib 1.3 mg/m2
other Names
Velcade
type
DRUG
arm Group Labels
Phase I Cohort - Bortezomib 1.6 mg/m2
Phase II Cohort
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
name
Bortezomib 1.6 mg/m2
other Names
Velcade
type
DRUG
arm Group Labels
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
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
name
Melphalan
other Names
Alkeran
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SEQUENTIAL

intervention Model Description

3 + 3 Dose Escalation

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 32
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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
measure
The Maximum Tolerated Dose of Bortezomib (MTD)
time Frame
During dosing of Bortezomib on Day -4 to Day -1 of ASCT

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice