AzTrials
AzTrials

Waldenström MacroglobulinemiaPhase 2NCT01536067

Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia

A Phase 2 study testing ofatumumab, bortezomib and laboratory biomarker analysis in people with Waldenström Macroglobulinemia, run by Roswell Park Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Waldenström Macroglobulinemia
What is being tested?
ofatumumab, bortezomib and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
Apr 2012to Apr 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of Waldenstrom Macroglobulinemia and presence of cluster of differentiation (CD)20+ tumor cells as determined by immune-histochemistry or flow cytometric analysis in bone marrow or representative lymphoid tissue specimen; to be deemed eligible, patients must meet at least one of the following criteria:
  • Rising immunoglobulin (Ig)M
  • Hemoglobin =< 10 g/dL
  • Platelet count =< 100 x 10^9/L
  • Symptomatic or bulky lymphadenopathy or organomegaly
  • Systemic manifestations of Waldenstrom Macroglobulinemia (WM), such as hyperviscosity symptoms (patients with symptoms of hyperviscosity syndrome must be treated with plasmapheresis to control the syndrome prior to enrollment), neuropathy, amyloidosis, cryoglobulinemia, B-symptoms, or recurrent bleeding
Show all 19Show fewer
  • Must have a measurable disease as defined by the monoclonal IgM level of 1 g/dL on serum protein electrophoresis (SPEP); if the level of IgM on SPEP is less than 1 g/dL in patients who meet any criteria in inclusion criteria 2, then the IgM level obtained from nephelometric measurement may be used to justify this criterion
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of =< 2
  • Have a life expectancy of >= 3 months
  • Absolute neutrophil count >= 1.0 x 10^9/L unless the result of disease infiltration of bone marrow
  • Platelet count >= 50 x 10^9/L unless the result of disease infiltration of bone marrow
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x the institutional upper limit of normal (ULN)
  • Total bilirubin =< 3 mg/dL or 1.5 x institutional ULN, whichever is lower
  • Serum creatinine =< 3 mg/dL
  • Female patients are either post-menopausal or surgically sterilized otherwise they must agree to use acceptable contraceptive methods (e.g. double barrier) during treatment
  • Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:
  • Practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug
  • Completely abstain from heterosexual intercourse
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure

Who cannot join

  • Pregnant and nursing female patients
  • Prior anti-neoplastic therapy for WM; the use of plasmapheresis to manage the symptoms of hyperviscosity and other IgM paraprotein mediated symptoms is allowed and does not disqualify a patient from the study; if a patient undergoes plasmapheresis within 8 weeks of starting the study treatment then the IgM level prior to plasmapheresis should be used for response assessment; neoplastic use of glucocorticoids is prohibited during the screening and treatment period; patients with active hyperviscosity symptoms should not be enrolled in this study unless the symptoms resolve after plasmapheresis
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment
  • Known human immunodeficiency virus (HIV) positive
Show all 15Show fewer
  • Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if HBsAg is negative and hepatitis B core antibody (HBcAb) is positive, regardless of hepatitis B surface antibody (HBsAb) status, a HB deoxyribonucleic acid test will be performed and if HB DNA is positive the patient will be excluded; if a patient is HBsAg negative, HBcAb positive, and HBsAb positive, indicating past but not active infection, the patient will be included on the study
  • Positive serology for hepatitis C (HC) defined as a positive test for Hep C by enzyme immunoassays (EIA), in which case reflexively perform a HC recombinant immunoblot assay (RIBA) on the same sample to confirm the result
  • Diagnosis of a malignant disorder other than WM within 3 years of the study enrollment with the exception of completely resected non-melanoma skin cancer and successfully treated in-situ cancer
  • Uncontrolled infection
  • Hypersensitivity to bortezomib, boron, or mannitol
  • Grade 2 or greater peripheral neuropathy; since WM is known to cause peripheral neuropathy (PN), if, in investigator's judgement, a patient has Grade 2 PN related to WM, then he/she can be enrolled onto the study; under no circumstances patient with greater than Grade 2 PN can be enrolled
  • Myocardial infarction within 6 months of enrollment; New York Heart Association (NYHA) Class III or more heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias; arrhythmias requiring active therapy other than chronic stable atrial fibrillation; if a patient has an implanted cardiac pacemaker and is otherwise well can be enrolled onto this study after demonstrating normal ejection fraction and clearance from a cardiologist; at the time of screening any electrocardiographic abnormality has to be documented as not medically relevant by the investigator before the patient proceeds to the enrollment phase
  • Any serious medical or psychiatric illness that may interfere with participation in the study
  • Patients with symptoms of hyperviscosity syndrome will not be enrolled on the study until they undergo plasmapheresis that results in resolution of symptoms and optimal control of the syndrome

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Weill Cornell Medical College

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Multicenter Phase II Study of Ofatumumab and Bortezomib (OB) in Previously Untreated Patients With Waldenstrom Macroglobulinemia

This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with previously untreated Waldenstrom macroglobulinemia. Monoclonal antibodies, such as ofatumumab and bortezomib, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving ofatumumab together with bortezomib may be a better way to block cancer growth

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine overall response rate (complete response [CR] + partial response [PR] + minor response [MR]) of ofatumumab in combination with bortezomib.

SECONDARY OBJECTIVES:

  1. Determine complete remission (CR) rate, near (n)CR rate, very good partial response (VGPR) rate and PR rate per new criteria.

II. Determine 5 year progression free survival (PFS). III. Determine time to progression and duration of response of ofatumumab in conjunction with bortezomib.

IV. Determine safety of ofatumumab in combination with bortezomib. V. Conduct laboratory correlates.

OUTLINE:

INDUCTION PHASE: Patients receive ofatumumab intravenously (IV) on days 1, 8, and 15 and bortezomib subcutaneously (SC) on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 5 years.

Being tested
ofatumumab, bortezomib, laboratory biomarker analysis
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

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

  • ofatumumabBiological

    Also called Arzerra, HuMax-CD20

    Given IV

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01536067
Study groupRoleWhat they receive
Treatment (monoclonal antibody therapy)ExperimentalINDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: ofatumumab; Drug: bortezomib; Other: laboratory biomarker analysis

What is being measured

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

  1. Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib

    Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.

    Measured: Every 28 days

Secondary outcomes (8)

  1. Frequency of Complete Remission (CR)

    Measured: Every 28 days

  2. Frequency of Near (n)CR

    Measured: Every 28 days

  3. Frequency of Very Good Partial Response (VGPR)

    Measured: Every 28 days

  4. Frequency of PR

    Measured: Every 28 days

  5. Time to Progression

    Measured: From start of treatment to disease progression, assessed up to 12 months

  6. Progression-free Survival

    Measured: From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 months

  7. Duration of Response

    Measured: From the observation of a response to the time of disease progression, assessed up to 12 months

  8. Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0

    Maximum grade per participant of any AE.

    Measured: Every 30 days for 2 months

Timeline

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

  1. First posted20 Feb 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2014

Why it stopped: funding was withdrawn

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536067
Sponsor's protocol ID
I 205011
Other IDs
NCI-2011-03816
Status last verified
May 2016
First submitted
10 Feb 2012
Last updated
10 Jun 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ofatumumab, bortezomib and laboratory biomarker analysis in people with Waldenström Macroglobulinemia, run by Roswell Park Cancer Institute at 2 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 19 inclusion and 15 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: stopped early, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 10 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib (time frame: Every 28 days). 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 NCT01536067.

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 10 Jun 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in