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MucositisPhase 1NCT00482846

Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma

A Phase 1 study testing Palifermin, melphalan and questionnaire administration in people with Mucositis and Multiple Myeloma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucositis, Multiple Myeloma
What is being tested?
Palifermin, melphalan and questionnaire administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
Jun 2007to Sep 2012
Phase
Phase 1
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
  • Stage II or III disease
  • Must have undergone successful stem cell mobilization (≥ 2.0 x 10^6 CD34+ cells/kg)
  • No oral lesions from any other etiology
  • No unhealed mucositis from induction treatment

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Amylase and lipase normal
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN
  • Creatinine normal (stratum 1 only)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No history of allergic reaction attributed to melphalan
  • No uncontrolled illness, including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • No psychiatric illness or social situation that would preclude study compliance
  • No hepatitis B or C positivity
  • No prior or concurrent pancreatitis
  • No known sensitivity to any of the study drugs, including E. coli-derived products

PRIOR CONCURRENT THERAPY:

  • Prior bone marrow or stem cell transplantation allowed
  • No prior palifermin
  • More than 30 days since prior investigational agents
  • No concurrent dialysis
  • No concurrent amifostine
  • No concurrent prophylactic oral cryotherapy during melphalan administration
  • No concurrent mouthwash solutions containing any of the following:
  • Chlorhexidine
  • Hydrogen peroxide
  • Diphenhydramine hydrochloride
  • No concurrent recombinant interleukin-11 or sargramostim (GM-CSF)
  • No concurrent sucralfate in suspension form
  • Sucralfate tablets allowed
  • No concurrent povidone-iodine rinses
  • No concurrent glutamine as a prophylactic agent for mucositis
  • No other concurrent investigational agents
  • No concurrent antithymocyte globulin suppression or alemtuzumab
  • No concurrent rituximab

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

Official title: Phase I Dose Escalation Trial of High Dose Melphalan Conditioning Regimen With Palifermin for Cytoprotection Followed by Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Keratinocyte growth factors, such as palifermin, may help prevent symptoms of mucositis, or mouth sores, in patients receiving melphalan before a peripheral stem cell transplant for multiple myeloma.

PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with palifermin in treating patients undergoing an autologous peripheral stem cell transplant for stage II or stage III multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of high-dose melphalan when administered with palifermin in patients undergoing autologous peripheral blood stem cell transplantation for stage II or III multiple myeloma.

Secondary

  • Assess overall response (complete and partial response and stable disease) in these patients at 28 and 100 days post-transplantation.
  • Assess the efficacy of palifermin as a cytoprotective agent in reducing incidence and duration of mucositis in patients treated with this regimen.
  • Assess patient-reported outcomes and impact of palifermin on quality of life of these patients.
  • Assess the qualitative and quantitative toxicities of this regimen in these patients.

OUTLINE: This is a dose-escalation study of melphalan. Patients are stratified according to creatinine clearance (normal vs < 60 mL/min).

Patients receive high-dose melphalan IV on day -2 and palifermin IV on days -5 to -3 and 1-3. Patients undergo autologous peripheral blood stem cell transplantation on day 0.

In each stratum, cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients complete questionnaires about overall health, mouth and throat soreness (MTS), and activity limitations due to MTS once daily on days -5 to 28.

After completion of study treatment, patients are followed at days 28 and 100 and then periodically thereafter.

Being tested
Palifermin, melphalan, questionnaire administration, autologous peripheral blood stem cell transplantation, quality-of-life assessment
Keywords
mucositis, drug/agent toxicity by tissue/organ, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Medical subject headings
Mucositis, Multiple Myeloma, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaliferminBiological

    Also called Kepivance

    Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3

  • melphalanDrug

    Also called Alkeran

    Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:

    Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;

    Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.:

    Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;

  • questionnaire administrationOther

    Day -5 to Day +28

  • autologous peripheral blood stem cell transplantationProcedure or surgery

    Day 0

  • quality-of-life assessmentOther

    Day -5 to Day +28

Study groups in NCT00482846
Study groupRoleWhat they receive
Palifermin & MelphalenExperimentalPalifermin 60 mcg/kg/d of the actual body weight unless actual body weight is >40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3 Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2: Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V; Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. <60)adm. via I.V.: Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;
Receives: Biological: Palifermin; Drug: melphalan; Other: questionnaire administration; Procedure: autologous peripheral blood stem cell transplantation; Other: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of melphalan when treated with palifermin to prevent mucositis

    Measured: Days -5, -4, -3, 2, +1, +2 and +3

Secondary outcomes (4)

  1. Dose-limiting toxicity

    Measured: Days -5, -4, -3, 2, +1, +2 and +3

  2. Evaluate the efficacy of Palifermin as a cytoprotective agent in reducing incidence and duration of Grade 3 and 4 mucositis due to high dose Melphlan

    Measured: Day -5 to Day +28

  3. Overall response

    Measured: At Day 28 and Day100 after autologous transplant when treated with combination of palifermin and Melphalan

  4. Reduction in incidence and duration of mucositis

    Measured: Days -5 to Day +28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2011
  4. Study completionSep 2012

Resources

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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482846
Sponsor's protocol ID
CDR0000547155
Other IDs
P30CA022453, WSU-2006-119
Status last verified
Apr 2014
First submitted
4 Jun 2007
Last updated
15 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Palifermin, melphalan and questionnaire administration in people with Mucositis and Multiple Myeloma, run by Barbara Ann Karmanos Cancer Institute 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 15 Apr 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

What does the primary outcome measure?

Maximum tolerated dose of melphalan when treated with palifermin to prevent mucositis (time frame: Days -5, -4, -3, 2, +1, +2 and +3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00482846.

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 15 Apr 2014.

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