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Multiple MyelomaPhase 1NCT00729118

Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 1 study testing lenalidomide and vorinostat in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Ohio State University Comprehensive Cancer Center 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: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Plasma Cell Neoplasm
What is being tested?
lenalidomide and vorinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
26 Sep 2008to 4 May 2020
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
  • Has undergone melphalan-conditioned autologous peripheral blood stem cell transplant myeloma.

PATIENT CHARACTERISTICS:

  • ECOG/WHO performance status 0-2
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 2 times ULN
  • Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 90 days after completion of study treatment
  • No blood, sperm, or ova donation during and for ≥ 4 weeks after completion of study treatment
  • Able to obtain commercially available lenalidomide via Celegene's RevAssist® program
  • Registered in the RevAssist® program
  • Willing and able to comply with the requirements of RevAssist®
  • Able to swallow capsules
  • No severe or uncontrolled systemic illness
  • No "currently active" second malignancy, other than nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Patients are not considered to have a "currently active" malignancy if they completed therapy for the malignancy, are disease free from the malignancy for > 5 years, and are considered by their physician to be at < 30% risk of relapse
  • No congenital long QT syndrome
  • No drug or alcohol abuse within the past 12 months
  • No history of allergic reactions (including erythema nodosum) attributed to compounds of similar chemical or biologic composition to lenalidomide, thalidomide, or vorinostat
  • No other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior class Ia, Ib, or Ic antiarrhythmic medication
  • No prior HDAC inhibitor-like compounds (e.g., valproic acid) as anticancer therapy
  • More than 30 days since prior HDAC inhibitor-like compounds for other indications (e.g., valproic acid for epilepsy)
  • No prior gastrointestinal surgery or other procedure that may, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs
  • No concurrent corticosteroids other than for physiologic maintenance treatment
  • No concurrent radiotherapy, unless for local control of bone pain
  • Irradiated area should be as small as possible
  • Lesions within the irradiated field cannot be used for response assessment
  • No concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and anticancer activity of the study drugs
  • No other concurrent anticancer therapy, including chemotherapy or biologic therapy
  • No other concurrent HDAC inhibitors (e.g., valproic acid)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the dose-limiting toxicities and safety of vorinostat and lenalidomide after autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
  • To evaluate the overall response rate to the combination of Vorinostat (SAHA) and lenalidomide.

Secondary

  • To evaluate the effect of this treatment regimen on natural killer cell activity and regulatory T cells in the post-transplant period.
  • To determine preliminary clinical activity of this treatment regimen by assessing overall survival and progression-free survival of these patients.
  • To obtain pilot data regarding an association between this treatment regimen and patient quality of life and circulating inflammatory cytokines.

OUTLINE: This is a dose-escalation study of vorinostat.

Patients receive oral vorinostat alone once daily on days 1-21 in course 1. For the second and subsequent courses, patients receive oral vorinostat in combination with oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative laboratory studies. Studies include functional immune assays (T-cell and natural killer cell activity and regulatory T-cell recovery) by fluorescence activated cell sorting (FACS) or ELISPOT; analysis of inflammatory markers (cytokines and catecholamines); and analysis of global H3 and H4 acetylation by immunohistochemistry.

Quality of life is assessed periodically using the Brief Pain Inventory (Short Form), The Center for Epidemiologic Studies Depression Scale (CES-D-10), a 9-item Brief Fatigue Inventory, and the FACT-G questionnaires.

After completion of study treatment, patients are followed for at least 30 days.

Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • lenalidomideDrug

    Also called Revlimid, CC-5013

    combined with Vorinostat (SAHA) days 1-21 of a 28-day cycle until progression or clinically significant toxicity.

  • vorinostatDrug

    Also called SAHA, Suberoylanilide hydroxamic acid

    Vorinostat (SAHA) will be administered orally beginning at dose level 1 starting day +90 ±6 days after HSCT for days 1 and 15-21 of a 28-day cycle combined with lenalidomide days 1-21 of a 28-day cycle until progression or clinically significant toxicity.

Study groups in NCT00729118
Study groupRoleWhat they receive
Lenalidomide + VorinostatExperimentalMaintenance post autologous transplant
Receives: Drug: lenalidomide; Drug: vorinostat

What is being measured

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

  1. Safety of patients receiving SAHA and lenalidomide following autologous PBSCT

    Patients will be assessed for Adverse events using the NCI CTCAE version 4.0 criteria

    Measured: up to 3 years

Secondary outcomes (7)
  1. Duration of response

    The time from progression to death

    Measured: up to 3 years

  2. Time to progression (TTP)

    Patients will be assessed for TTP from the start of treatment until the date of progression.

    Measured: up to 3 years

  3. Progression-free survival (PFS)

    PFS is the time from the first dose a patient receives until disease progression or death at trial closure.

    Measured: up to 3 years

  4. Time to response

    From the first dose of study therapy until measurement criteria are first met progressive response (PR), complete response (CR) or stable disease (SD). The patients best response is recorded.

    Measured: up to 3 years

  5. Duration of overall response

    The duration computed for subjects whose best response is either PR or CR or SD and is measured when first met for complete or partial response(whichever comes first) until first date of progressive disease or death

    Measured: up to 3 years

  6. Overall survival

    The survival time defined as the time from start of treatment to the date of death.

    Measured: up to 3 years

  7. Response rate

    Tumor response defined as the total number of patients whose best response is PR or CR or SD, divided by the number of patients

    Measured: up to 3 years

Timeline

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

  1. First posted7 Aug 2008 (estimated)
  2. Study start26 Sep 2008
  3. Primary completion26 Dec 2019
  4. Study completion4 May 2020

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00729118
Sponsor's protocol ID
OSU-08001
Other IDs
NCI-2011-03140
Status last verified
May 2020
First submitted
6 Aug 2008
Last updated
18 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sborov DW, Benson DM, Williams N, Huang Y, Bowers MA, Humphries K, Efebera Y, Devine S, Hofmeister CC. Lenalidomide and vorinostat maintenance after autologous transplant in multiple myeloma. Br J Haematol. 2015 Oct;171(1):74-83. doi: 10.1111/bjh.13527. Epub 2015 Jun 8.

    PubMed 26058589

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide and vorinostat in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Ohio State University Comprehensive Cancer Center 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 18 May 2020. 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?

Safety of patients receiving SAHA and lenalidomide following autologous PBSCT (time frame: up to 3 years). 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 NCT00729118, 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 18 May 2020.

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