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Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy


The primary objectives of this study are:

- To determine the 2 year-progression free survival in multiple myeloma with an
allogeneic transplant using a conditioning regimen of melphalan + fludarabine +
Bortezomib in patients < 60 years of age and available HLA-matched donor and compare it
with the 2 year-progression-free-survival after an autologous stem cell transplant with
melphalan+Bortezomib conditioning in patients < 60 years.

- To determine the 2 year-progression free survival in multiple myeloma with an
autologous stem cell transplant using a conditioning regimen of melphalan + Bortezomib.
for patients > 60 years of age and patients < 60 years of age who decline allogeneic
stem cell transplant.

The secondary objectives of this study are:

- To determine the overall survival in multiple myeloma with autologous or allogeneic
stem cell transplants using the above conditioning regimens

- To determine the response rates in multiple myeloma using the above regimens.

- To determine minimal residual disease status using allele specific oligonucleotides
(ASO-PCR) by PCR and flow-cytometry for multiple myeloma cells.

- To correlate minimal residual disease status with 2 year progression free survival and
overall survival.

- To determine the incidence of acute and chronic GVHD in multiple myeloma with
allogeneic stem cell transplant using the above conditioning regimen.

- To examine quality of life in patients treated with allogeneic and autologous stem cell
transplants using the above conditioning regimen.


Inclusion Criteria:



Multiple Myeloma Criteria(International Uniform Response Criteria for Multiple Myeloma)

- Patients with responsive disease after any line of induction therapy

- A complete response

- A very good partial response

- A partial response

- Patients greater than or equal to 18 years of age are eligible. There is upper age
limit of 60 years for allogeneic transplants.

- Patients must have a histologically confirmed diagnosis.

- All patients should have a life expectancy of at least 12 weeks.

- Patients must have undergone a complete psychosocial evaluation and have been
considered capable of compliance.

- Meet the following criteria for allogeneic hematopoietic cell transplant:

- Must have an identified donor match defined as: HLA-A, HLA-B, HLA- C, DRB1 8/8
allele matched sibling, family member, or unrelated donor. [7/8 would go on separate
mismatched trials] and be < 60 years of age.

- Calculated hematopoietic cell transplantation-specific comorbidity index (HCT-CI) <3

Exclusion Criteria:

- Patients who do not achieve at least a partial response (PR) by the criteria
mentioned above with induction therapy.

- Patient has a platelet count of <30 x 10^9/L within 14 days before enrollment.

- Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.

- Patient has an absolute neutrophil count of <1.0 x 10^9/L within 14 days before
enrollment.

- Myocardial infarction within 6 months prior to enrollment or has New York Hospital
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities. Prior to study entry, any ECG
abnormality at screening has to be documented by the investigator as not medically
relevant in order for the subject to be considered eligible. LVEF by MUGA scan < 40%

- Patient has hypersensitivity to bortezomib, boron or mannitol.

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum beta-human chorionic gonadotropin
(beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.

- Patient has received other investigational drugs with 14 days before enrollment

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Patients with a DLCO less than 50% (adjusted) of normal or with symptomatic
obstructive or restrictive lung disease are ineligible.

- Patients with a total bilirubin greater than 2.0 mg/dL excluding Gilbert's syndrome
and SGOT or SGPT greater than two and a half times normal (unless due to primary
malignancy), or a history of severe hepatic dysfunction are ineligible.

- Calculated creatinine clearance
- Patients with active infections are ineligible.

- Patients who are HIV positive are ineligible.

- Patients with active leptomeningeal involvement are ineligible. Patients with a
history of previous CSF tumor involvement without symptoms or signs are eligible
provided the CSF is now free of disease on lumbar puncture, and MRI of the brain
shows no tumor involvement. Patients with severe symptomatic CNS disease of any
etiology are ineligible.

- Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major
thyroid or adrenal dysfunction are ineligible.

- Patients with an ECOG performance status of >/= 2(Karnofsky < 50%) are ineligible.

- Patients with an ECOG performance status of 2 to 3(Karnofsky 30-50%), secondary to
bone pain, may be enrolled.

- Patients with an ECOG performance status of 2 to 3(Karnofsky 30-50%), secondary to a
potentially reversible disease-related problem, may be enrolled.

- Patients with any previous malignancy other than non-melanoma skin cancer are
ineligible, unless the patient is without evidence of disease >/= 5 years after the
treatment for the cancer was completed.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival with allogeneic stem cell transplant in multiple myeloma using melphalan+fludarabine+bortezomib as the conditioning regimen

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Melissa Alsina, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC 15697

NCT ID:

NCT00948922

Start Date:

June 2009

Completion Date:

July 2013

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • myeloma
  • myeloma proteins
  • autologous
  • allogeneic
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

H. Lee Moffitt Cancer CenterTampa, Florida  33612