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DS Stage I Plasma Cell MyelomaPhase 2NCT00088855

Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma

A Phase 2 study testing Bortezomib, Laboratory Biomarker Analysis and Pegylated Liposomal Doxorubicin Hydrochloride in people with DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, run by National Cancer Institute (NCI) at 25 sites 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

This phase II trial studies the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bortezomib, Laboratory Biomarker Analysis and Pegylated Liposomal Doxorubicin Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
25 sitesUnited States
Study dates
15 Jun 2004to 8 Jan 2008
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

Who may be able to join

  • Patients must have a histologically confirmed diagnosis of symptomatic multiple myeloma with evaluable disease parameters
  • A diagnosis of symptomatic multiple myeloma requires:
  • A monoclonal serum and/or urine protein
  • Clonal bone marrow plasmacytosis, or a histologically confirmed plasmacytoma
  • Related organ or tissue impairment, consisting of:
  • Hypercalcemia (serum calcium > 0.25 mmol/l above the upper limit of normal, or > 2.75 mmol/l [i.e. > 11.5 mg/dl]) AND/OR
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  • Renal insufficiency (serum creatinine > 173 mmol/l [i.e., > 2 mg/dL]); (please note that serum creatinine may not be >= 2.5 mg/dL) AND/OR
  • Anemia (hemoglobin 2 g/dl below the lower limit of normal, or hemoglobin < 10 g/dl) AND/OR
  • Bony lesions (lytic bony lesions, or osteoporosis with compression fractures) AND/OR
  • Other findings, such as symptomatic hyperviscosity, amyloidosis, or recurring bacterial infections (> 2 episodes in 12 months)
  • Patients may not have undergone any prior therapy, with the following exceptions:
  • Prior plasmapheresis with plasma exchange (PLEX) for a hyperviscosity syndrome is allowed, providing the patient has no current evidence of hyperviscosity and has not required PLEX for at least one week prior to initiation of therapy
  • Prior radiation therapy to areas of spinal cord compression by plasmacytomas, painful lesions due to bony involvement, or other myeloma-related indications, is allowed provided that radiation will have been completed 3 weeks before initiation of therapy
  • Prior surgical intervention, such as for bony fractures or other myeloma-related complications, is allowed provided that this will have been completed 3 weeks before the initiation of therapy, and patients have recovered from surgery
  • Prior therapy with corticosteroids for indications other than multiple myeloma is allowed, provided such therapy has been discontinued at least two weeks prior to study entry, and at least two weeks before their baseline disease evaluation
  • Prior supportive therapy with bisphosphonates or erythropoietin is allowed
  • Inclusion of females of childbearing potential requires a negative pregnancy test
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Patients may not have a prior history of a hypersensitivity reaction to pegylated liposomal doxorubicin or doxorubicin, bortezomib or other boronic acid-based compounds
  • Patients with a history of reactions to liposomal drug formulations other than pegylated liposomal doxorubicin will be evaluated individually, and if their reactions were felt to have been due to the liposomal component itself, as opposed to the encapsulated agent, they will be excluded at the discretion of the investigators
  • Patients who are known to be human immunodeficiency virus (HIV)-seropositive and are taking anti-retrovirals may not participate in this study; patients who are HIV-seropositive and not on anti-retroviral therapy, and who otherwise meet the organ function criteria, will be eligible for the study
  • Patients who are known to have active hepatitis A, B, or C viral infection may not participate in this study
  • No electrocardiogram (EKG) evidence of acute ischemia
  • No EKG evidence of medically significant conduction system abnormalities
  • No history of myocardial infarction within the last 6 months
  • Left ventricular ejection fraction (LVEF) must be >= 45% by either echocardiography or radionuclide-based multiple gated acquisition (radionuclide ventriculography [RNV] or multiple gate acquisition scan [MUGA])
  • No class 3 or class 4 New York Heart Association congestive heart failure
  • Creatinine < 2.5 mg/dL
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 times the upper limit of the institutional normal value
  • Total bilirubin =< 1.2 times the upper limit of the institutional normal value
  • Absolute neutrophil count (ANC) >= 1,000/ul
  • Platelets >= 100,000/ul
  • Hemoglobin >= 8 g/dl (transfusion- and/or growth factor-dependent patients are not excluded if the above parameters can be achieved with such support)
  • For those patients receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications

Who cannot join

None listed.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Lenoir Memorial Hospital

    Kinston, North Carolina, 28501

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Frisbie Hospital

    Rochester, New Hampshire, 03867

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma

This phase II trial studies the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment. Bortezomib and pegylated liposomal doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the complete response (CR) + near-complete response (nCR) rate of the bortezomib/pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) regimen in patients with previously untreated, symptomatic multiple myeloma.

II. To evaluate the toxicity of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.

SECONDARY OBJECTIVES:

  1. To evaluate the overall response rate, including patients with CR, nCR, and partial response (PR), of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.

II. To evaluate the impact of therapy with the bortezomib/pegylated liposomal doxorubicin regimen on the ability to collect peripheral blood stem cells in those patients going on to subsequent autologous stem cell transplantation.

III. To evaluate the time to progression (TTP) in all patients receiving bortezomib/pegylated liposomal doxorubicin therapy, both those who go on to autologous stem cell transplantation and those who do not go on to transplantation.

IV. To evaluate the value of early changes in levels of serum interleukin 6 (IL-6) and macrophage inflammatory protein 1 alpha (MIP-1α) as predictors of response to bortezomib/pegylated liposomal doxorubicin.

  1. To correlate pre-treatment clinical and biological characteristics with response to therapy and toxicity.

OUTLINE:

Patients receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 weeks for 2 years and then every 6 months for 3 years.

Being tested
Bortezomib, Laboratory Biomarker Analysis, Pegylated Liposomal Doxorubicin Hydrochloride

What participants receive

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

  • BortezomibDrug

    Also called [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pegylated Liposomal Doxorubicin HydrochlorideDrug

    Also called ATI-0918, Caelyx, DOX-SL, Doxil

    Given IV

Study groups in NCT00088855
Study groupRoleWhat they receive
Treatment (bortezomib and pegylated liposomal doxorubicin)ExperimentalPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Bortezomib; Other: Laboratory Biomarker Analysis; Drug: Pegylated Liposomal Doxorubicin Hydrochloride

What is being measured

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

  1. CR+nCR rate

    Will be estimated with an exact 90% confidence interval.

    Measured: After 18 weeks (6 courses of treatment)

Secondary outcomes (6)

  1. CR+nCR+PR rate

    Will be estimated with an exact 90% confidence interval.

    Measured: After 18 weeks (6 courses of treatment)

  2. Maximal response rate

    Measured: After 18 weeks (6 courses of treatment)

  3. Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Toxicities will be tabulated by type and grade.

    Measured: Up to 5 years

  4. Progression-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years

  5. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: From on-study date to the date of death, assessed up to 5 years

  6. Changes in IL-6 and MIP-1

    The association of response with pre-treatment characteristics such as cytogenetics and fluorescence in situ hybridization and with early changes in IL-6 and MIP-1 will be described by reporting response rates (and their confidence intervals) according to subgroup (e.g., response rates by age group; response rates by large/small change in IL-6 level).

    Measured: Baseline to up to day 2 of course 1

Timeline

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

  1. First posted5 Aug 2004 (estimated)
  2. Study start15 Jun 2004
  3. Primary completion31 Oct 2006
  4. Study completion8 Jan 2008

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00088855
Sponsor's protocol ID
NCI-2014-01607
Other IDs
NCI-2014-01607, NCI-2012-02810, CDR377483, CALGB 10301, CALGB-10301, U10CA180821, U10CA031946
Status last verified
Sep 2019
First submitted
4 Aug 2004
Last updated
23 Sep 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib, Laboratory Biomarker Analysis and Pegylated Liposomal Doxorubicin Hydrochloride in people with DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, run by National Cancer Institute (NCI) at 25 sites 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?

The sponsor lists 34 inclusion and 0 exclusion criteria. 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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.

What does the primary outcome measure?

CR+nCR rate (time frame: After 18 weeks (6 courses of treatment)). 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 NCT00088855.

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 23 Sep 2019.

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