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Relapsed or Refractory Multiple MyelomaPhase 1/2rev/abraxaneNCT02075021

Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Lenalidomide and nab-paclitaxel in people with Relapsed or Refractory Multiple Myeloma, run by NYU Langone Health at 1 site in United States.

Terminated

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

Official record
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Trial summary

The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot phase II trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Lenalidomide and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Mar 2014to Nov 2015
Phase
Phase 1/2
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

  • Patients with relapsed/refractory multiple myeloma based on standard criteria
  • Renal function assessed by calculated creatinine clearance as follows
  • Phase I subjects must have calculated creatinine clearance >=30ml/min by Cockcroft-Gault formula.
  • Phase II subjects must have calculated creatinine clearance >=30ml/min by Cockcroft-Gault formula.
  • Progressed (>25% increase in evaluable disease) or non response on Revlimid or within 60 days of stopping Revlimid
  • > 1 prior regimen
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  • Total bilirubin <=1.5 x Upper limit of normal (ULN)
  • AST (aspartate aminotransferase) or serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT) <=3 x ULN.
  • All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®.
  • Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL (milli-International unit/milliliter) within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA (acetylsalicylic acid) may use warfarin or low molecular weight heparin).
  • With < or = grade 2 neuropathy
  • Karnofsky performance status ≥ 50
  • Patients treated with local radiotherapy with or without a brief (2 weeks or less) exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed
  • Meets the following pretreatment laboratory criteria at Baseline (Day 1 of Cycle 1, before study drug administration)
  • Platelet count ≥ 75 x 10^3/uL (upper limit) .
  • Hemoglobin ≥ 8.0 g/dL (grams/deciliter)
  • Absolute neutrophil count ≥ 1.0 x 10^3/uL
  • Age 18 years or older

Who cannot join

  • > grade 2 neuropathy
  • > Cr (complete response) 2.5
  • LFTs (liver function test) > 2x nl (normal limit)
  • Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG (electrocardiogram) abnormality at screening must be documented by the investigator as not medically relevant.
  • Known hypersensitivity to thalidomide or Revlimid (if applicable).
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
  • Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • 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.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
  • Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
  • POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
  • Plasma cell leukemia
  • Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
  • Infection not controlled by antibiotics
  • HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice
  • Known active hepatitis B or C

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot phase II trial. All treatments will be performed until progression. Assessments will be made at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression.

The purpose of this research study is to determine how much of the combination of Revlimid and Abraxane can be given safely and how well they work together against the cancer.

Currently, this trial is in the phase 1 stage.

Read the detailed description

Revlimid is an important imid based therapy of myeloma. However patients will still relapse after this drug and then have limited options. Abraxane has shown efficacy in a number of cancers, putatively through intratumor concentration by SPARC (secreted protein acidic and rich in cysteine). (Taxanes have shown a modest activity in myeloma. Interestingly, Revlimid can upregulate the levels of SPARC. Thus, investigators will test the toxicity and efficacy of a combination of Revlimid and Abraxane in relapsed/refractory myeloma.

Investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane weekly for 3 weeks in patients who have failed Revlimid but have adequate blood counts and renal function and minimal neuropathy. For study purposes, 1 cycle is considered to be 4 weeks (20 days). Subjects will get Abraxane for three weeks and will be off of this treatment for 1 week. There are 10 visits per cycle. Accrual will be on standard 3 patient cohorts. Once the maximum tolerated dose is reached, the level below will be expanded to 25 patients for a pilot phase II trial. All treatments will be performed until progression. Assessments will be made at least at the 2, 4, and 6 month timepoints and monthly thereafter until progression.

Since both drugs can cause myelosuppression, investigators will start with doses below their standard doses as single agents. Investigators will use 100 mg/m2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. Dose de-escalations will also be performed for both drugs as necessary. Investigators will explore whether SPARC (secreted protein acidic and rich in cysteine) expression is altered by flow cytometry and immunohistochemistry.

Keywords
relapsed, refractory, multiple myeloma, revlimid, lenalidomide, abraxane, n-paclitaxel
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

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

Study groups in NCT02075021
Study groupRoleWhat they receive
lenalidomide and nab-paclitaxelExperimental100 mg/m^2 of Abraxane weekly for 3 weeks and 10 mg Revlimid daily for 21 days, with a dose escalation for Revlimid to 15 mg and to 25 mg. One cycle is 4 weeks. Dose de-escalations will also be performed for both drugs as necessary. Patients will be treated until disease progression.
Receives: Drug: Lenalidomide; Drug: nab-paclitaxel

What is being measured

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

  1. Maximum Tolerated Dose (Phase I)

    Dose limiting toxicity will be accessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: 4 weeks

Secondary outcomes (1)

  1. the Number of Patients Who Achieve Complete Response (CR) or Partial Response (PR) (Phase II)

    The response will be determined using the International Uniform Response Criteria for Multiple Myeloma.

    Measured: up to 2 years

Timeline

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

  1. First posted3 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Why it stopped: PI left the institution

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075021
Sponsor's protocol ID
12-02519
Acronym
rev/abraxane
Status last verified
Sep 2018
First submitted
27 Feb 2014
Last updated
15 Oct 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide and nab-paclitaxel in people with Relapsed or Refractory Multiple Myeloma, run by NYU Langone Health 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 19 inclusion and 19 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 15 Oct 2018. 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 combined 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.

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 5 Sep 2017). 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?

Maximum Tolerated Dose (Phase I) (time frame: 4 weeks). 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 NCT02075021.

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 Oct 2018.

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