Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00008268
Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
A Phase 2 study testing filgrastim and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- filgrastim and melphalan
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jun 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Must have received induction therapy within the past 3 months
- Chemoresponsive disease
- Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory
- No symptomatic pleural effusions
- Eligible for stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy)
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
Renal:
- Creatinine no greater than 2.5 mg/dL OR
- Creatinine clearance greater than 51 mL/min
Cardiovascular:
- No symptomatic cardiomyopathy
- No medically documented symptomatic cardiac arrhythmias within the past 60 days
- No New York Heart Association class III congestive heart failure
- No myocardial infarction within the past 6 months
Other:
- No other concurrent medical conditions that would preclude study
- No uncontrolled infections
- No other active malignancy within the past 5 years except for non-melanoma skin cancer
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior stem cell mobilization or transplantation
Chemotherapy:
- See Disease Characteristics
- No more than 200 mg prior oral melphalan
Endocrine therapy:
- Not specified
Radiotherapy:
- No more than 3000 cGy of prior radiotherapy for myeloma
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma
RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.
Read the detailed description
OBJECTIVES:
- Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.
- Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.
- Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients.
OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.
- Being tested
- filgrastim, melphalan
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
melphalanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Raymond L. Comenzo, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008268
- Sponsor's protocol ID
- 00-067
- Other IDs
- CDR0000068392, NCI-G00-1895
- Status last verified
- Jun 2013
- First submitted
- 6 Jan 2001
- Last updated
- 18 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00008268
- Acronym / sponsor ID
- 00-067
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2000
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.
Detailed description
OBJECTIVES:
- Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.
- Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.
- Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients.
OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| melphalan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond L. Comenzo, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.