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Multiple MyelomaPhase 1NCT01114282

Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM

A Phase 1 study testing velcade and Pralatrexate in people with Multiple Myeloma, run by Stanford University 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

The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib (VELCADE) in combination with pralatrexate in patients with previously treated multiple myeloma, AL amyloid and Waldenstroem's macroglobulinemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
velcade and Pralatrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Aug 2010to Feb 2014
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

Who may be able to join

  • The patient has relapsed or refractory multiple myeloma that has progressed following at least on prior therapy.
  • Relapsed myeloma is defined in patients as at least 25% increasing monoclonal (M)-protein in serum or urine or in the size of a plasmacytoma compared to a best response reached after previous therapy.
  • Refractory myeloma is defined as failure to achieve at least a minor response (patient achieved stable disease as his/her best response) or progression of disease on current therapy or within 60 days of last dose of current therapy.
  • The patient has measurable disease defined as one of the following:
  • serum M-protein >=1 g/dL
  • urine M-protein >=200 mg/24 hours
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  • Must have received at least one (1) prior line of systemic treatment that may have included VELCADE.
  • NOTE: Patients may have undergone prior allogeneic or autologous stem cell transplantation (stem cell transplant with high dose induction chemotherapy with/without planned maintenance therapy will be considered one line of therapy).
  • No cytotoxic chemotherapy within 4 weeks prior to registration for protocol therapy.
  • NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide, VELCADE or corticosteroids, provided other entry criteria are met.
  • No concurrent steroid use in doses greater than 10 mg daily of Prednisone (or equivalent) if given for management of co-morbid conditions.
  • Age >= 18 at the time of consent.
  • The patient has a life expectancy of more than 3 months.
  • No known central nervous system involvement by myeloma.
  • ECOG performance status 0-2.
  • No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, or psychiatric illness that in the opinion of the investigator would limit compliance with study requirements.
  • Patients must have adequate bone marrow function: Platelets >100 x 109/L, Hemoglobin > 8.0g/dL and ANC > 1 x 109/L
  • Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of normal, Total bilirubin <= 1.5 x ULN
  • Patients must have adequate renal function defined as creatinine clearance of 30 ml/minute (Cockcroft-Gault).
  • The patient must have been on a regimen of 1.0 - 1.25 mg PO QD of folic acid for at least 10 days prior to the planned start of pralatrexate and received 1 mg IM of vitamin B12 within 10 weeks of the planned start of pralatrexate.
  • Patients with reproductive potential must use an effective method of contraception to avoid pregnancy for the duration of the trial.
  • If female of childbearing potential, pregnancy test must be negative within 7 days prior to registration for protocol therapy.
  • Ability to understand and the willingness to sign a written informed consent document including HIPAA authorization for release of personal health information.
  • The patient must be willing and able to receive outpatient treatment and laboratory monitoring at the Stanford Cancer Center.

Who cannot join

  • The patient has nonmeasurable multiple myeloma, defined as less than 1g/dl M-protein in serum and less than 200 mg/24 hours M-protein in urine.
  • The patient received glucocorticoid therapy (prednisone > 10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug.
  • The patient received chemotherapy with approved or investigative anticancer therapeutics within 4 weeks.
  • NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide, VELCADE or corticosteroids, provided other entry criteria are met.
  • The patient has an acute infection requiring systemic antibiotics, antiviral agents, or antifungal agents within 2 weeks before the first dose of study drug.
  • The patient has grade 2 or higher neuropathy within 14 days of enrollment.
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  • The patient has any serious psychiatric or medical condition that could interfere with treatment and study procedures, place the patient at unacceptable risk, or confound the ability of investigators to interpret study data.
  • The patient is a pregnant or lactating woman.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix A), 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.
  • Patient has hypersensitivity to VELCADE, boron or mannitol.
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase I Study of Bortezomib (VELCADE) in Combination With Pralatrexate in Relapsed/Refractory Multiple Myeloma

The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib (VELCADE) in combination with pralatrexate in patients with previously treated multiple myeloma, AL amyloid and Waldenstroem's macroglobulinemia.

Read the detailed description

This is an open-label Phase I dose-escalation safety study of VELCADE in combination with pralatrexate in patients with previously treated multiple myeloma. In a standard 3+3 dose escalation trial design, escalating doses of pralatrexate in combination with VELCADE will be studied sequentially, with at least 3 patients in each dose level until the MTD is determined. Dose limiting toxicity (DLT) and MTD are determined during cycle 1 of treatment.

Being tested
velcade, Pralatrexate
Medical subject headings
Multiple Myeloma

What participants receive

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

  • velcadeDrug

  • PralatrexateDrug

Study groups in NCT01114282
Study groupRoleWhat they receive
VELCADE with pralatrexateExperimentalPralatrexate,10 mg/m2, IV bolus on days 1, 8, and 15 VELCADE,1.3 mg/m2, IV bolus on days 1, 8, and 15
Receives: Drug: velcade; Drug: Pralatrexate

What is being measured

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

  1. The maximum tolerated dose (MTD) for the combination of pralatrexate with VELCADE in previously treated adult patients with multiple myeloma.

    Measured: assessed upon completion of cycle 1 of treatment

Secondary outcomes (5)

  1. Clinical evidence of anti-tumor activity based on response rates

    Measured: assessed after each 4 week cycle (up to 4 cycles)

  2. Time to progression (TTP)

    Measured: assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3-5 and annually thereafter

  3. Duration of Response Outcome

    Measured: assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3-5 and annually thereafter

  4. Progression free survival (PFS)

    Measured: assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3-5 and annually thereafter

  5. Overall survival (OS)

    Measured: assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3-5 and annually thereafter

Timeline

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

  1. First posted3 May 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionFeb 2014

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114282
Sponsor's protocol ID
HEMMYL0014
Other IDs
SU-04282010-5783
Status last verified
Jul 2016
First submitted
29 Apr 2010
Last updated
6 Jul 2016
Results posted
No

Publications

  • Dunn TJ, Dinner S, Price E, Coutre SE, Gotlib J, Hao Y, Berube C, Medeiros BC, Liedtke M. A phase 1, open-label, dose-escalation study of pralatrexate in combination with bortezomib in patients with relapsed/refractory multiple myeloma. Br J Haematol. 2016 Apr;173(2):253-9. doi: 10.1111/bjh.13946. Epub 2016 Apr 4.

    PubMed 27040320

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing velcade and Pralatrexate in people with Multiple Myeloma, run by Stanford University 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?

The sponsor lists 24 inclusion and 11 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 6 Jul 2016. 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?

The maximum tolerated dose (MTD) for the combination of pralatrexate with VELCADE in previously treated adult patients with multiple myeloma. (time frame: assessed upon completion of cycle 1 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 NCT01114282, which also lists 1 linked publication.

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 6 Jul 2016.

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