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.
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.
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.
- Conditions
- Multiple Myeloma, Plasma Cell Neoplasm
- Being tested
- lenalidomide, vorinostat
- 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 group | Role | What they receive |
|---|---|---|
| Lenalidomide + Vorinostat | Experimental | Maintenance 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.
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)
Duration of response
The time from progression to death
Measured: up to 3 years
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
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
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
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
Overall survival
The survival time defined as the time from start of treatment to the date of death.
Measured: up to 3 years
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.
- First posted7 Aug 2008 (estimated)
- Study start26 Sep 2008
- Primary completion26 Dec 2019
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Yvonne Efebera, Ohio State University Comprehensive Cancer Center
- Investigators
- Yvonne C. Efebera, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00729118
- Acronym / sponsor ID
- OSU-08001
- Conditions
- Multiple Myeloma, Plasma Cell Neoplasm
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 26 Sep 2008 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide + Vorinostat | Experimental | Drug: lenalidomide, Drug: vorinostatMaintenance post autologous transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomideAlso: Revlimid, CC-5013combined with Vorinostat (SAHA) days 1-21 of a 28-day cycle until progression or clinically significant toxicity. | Drug | Lenalidomide + Vorinostat |
| vorinostatAlso: SAHA, Suberoylanilide hydroxamic acidVorinostat (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. | Drug | Lenalidomide + Vorinostat |
Primary outcome
Safety of patients receiving SAHA and lenalidomide following autologous PBSCT
Time frame: up to 3 years
Patients will be assessed for Adverse events using the NCI CTCAE version 4.0 criteria
7 secondary outcomes
Duration of response
Time frame: up to 3 years
Time to progression (TTP)
Time frame: up to 3 years
Progression-free survival (PFS)
Time frame: up to 3 years
Time to response
Time frame: up to 3 years
Duration of overall response
Time frame: up to 3 years
Overall survival
Time frame: up to 3 years
Response rate
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Derived from this study: PubMed 26058589Sborov 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.
- JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne C. Efebera, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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.