Multiple MyelomaPhase 1/2RZDNCT01502085
Vorinostat,Lenalinomide and Dexamethasone in Multiple Myeloma Refractory to Previous Lenalinomide Containing Regimens
A Phase 1/2 study testing Vorinostat, Lenalinomide and Dexamethasone in people with Multiple Myeloma, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple myeloma. 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?
- Vorinostat, Lenalinomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to May 2016
- 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
- Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study:
- International Staging System symptomatic multiple myeloma, as recently defined (Kyle et al., 2009) or Durie-Salmon stage I-III multiple myeloma, after at least one (1) prior anti-myeloma regimen.
- Refractory to lenalidomide (administered either with dexamethasone or in combination with other agents); refractory will be defined as no response (<MR) or PD on or within 60 days of discontinuing a prior lenalidomide-containing regimen.
- Measurable monoclonal protein by serum or urine; or FLC level ≥ 10mg/dL (with abnormal FLC ratio), or measurable extramedullary plasmacytomas:
- No prior HDAC inhibitor
- Age ≥ 18 years
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- Performance status ECOG 0-3
- Acceptable organ function as defined by:
- Bilirubin <2 x upper limit of normal
- ALT and AST <2.5 x upper limit of normal
- Serum creatinine <3.0 mg/dL
- ANC ≥1.0 x 109/L
- Platelet count ≥50 x 109/L
- QTc interval ≤ 470ms
- Non-pregnant and non-lactating
- Life expectancy of more than six months
- Written informed consent in accordance with federal, local and institutional guidelines
- Females of Child Bearing Potential* (FCBP) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescription must be filled with 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO methods of acceptable methods of birth control, one highly effective method AND one additional effective method of birth control (contraception) AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy Testing. (See Appendix G: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods) *A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy (See Appendix G: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods)
- All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®.
- Subjects must adhere to the study visit schedule and other protocol requirements and receive outpatient treatment and laboratory monitoring at the institute that administers the drug.
- Subjects must agree to take enteric-coated aspirin 81-325 mg orally daily, or if history of prior thrombotic disease or allergy to aspirin, must be fully anticoagulated with warfarin (INR 2-3), Pradaxa® or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism.
Who cannot join
- Subjects must not meet any of the following exclusion criteria to be eligible to enroll in this study:
- Subjects with non-secretory or hyposecretory multiple myeloma, defined as <0.5 g/dL M-protein in serum and <200 mg/24 hr Bence Jones protein in urine and serum free light chain <10mg/dL (<100 mg/L)
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
- Pregnant or breast feeding females
- CrCl <30 ml/min or renal failure requiring hemodialysis
- Prior history or malignancy other than multiple myeloma, unless patient has been disease free of the disease for ≥3 years.
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- Prior or local irradiation within two weeks before screening
- Evidence of central nervous system (CNS) involvement
- Unable to take corticosteroids at study entry
- Peripheral neuropathy of ≥ grade 3 severity
- Inability or unwillingness to comply with birth control requirements
- Unable to take antithrombotic medicines at study entry
- Refusal to participate in study
- Persons protected by a legal regime (guardianship, trusteeship)
- Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 3 weeks prior to first dose
- Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- Known or suspected HIV infection, known HIV seropositivity, or active hepatitis A, B, or C infection
Trial locations and contacts
1 site in 1 country.
United States1 site
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: A Phase IIb Trial of Vorinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma Patients Refractory to Previous Lenalidomide Containing Regimens
Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple myeloma.
Read the detailed description
lenalidomide has been investigated in combination with both lenalidomide and bortezomib regimens. "Investigational" means that the drug is still being studied and that the study doctors are trying to find out more about it; such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating relapsed and/or refractory multiple myeloma.
Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental because the FDA has not approved this combination. Participants will receive 25mg of lenalidomide on days 1-21 every 28 days.
Vorinostat is a drug that interferes with the life sustaining functions of the tumor cells. It has already received regulatory approval by the U.S. Food and Drug Administration (FDA) for the treatment of T-cell non-Hodgkin's Lymphoma in the United States. The usage of vorinostat in Multiple Myeloma is experimental (investigational) and has not been approved by the FDA, but studies in combination with proteasome inhibitors (bortezomib) and immunomodulatory (lenalidomide) agents are ongoing. Participants will receive either 400mg of vorinostat on days 1-7 and 15-21 every 28 days.
Dexamethasone is a steroid that is known to cause cell death in multiple myeloma. Dexamethasone is FDA approved for the treatment of multiple myeloma and many other disease states. Participants will receive either Dexamethasone 40mg for those less than 75 years of age or 20mg for those aged 75 years and above on days 1, 8, 15 and 22 every 28 days In this research study the investigators are looking to evaluate the safety and efficacy of vorinostat when combined with lenalidomide and dexamethasone in treating relapsed and/or refractory multiple myeloma, refractory to lenalidomide.
- Conditions
- Multiple Myeloma
- Being tested
- Vorinostat, Lenalinomide and Dexamethasone
- Keywords
- multiple myeloma lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vorinostat, Lenalinomide and DexamethasoneDrug
Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21
- Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert
Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat, Lenalinomide, Dexamethasone | Experimental | Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21
* Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above Receives: Drug: Vorinostat, Lenalinomide and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (PR or Better) of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed/Refractory MM Refractory to a Previous Lenalidomide Containing Regimen
Defined as:
- Progression on therapy OR within 60 days after the last dose of a lenalidomide containing regimen OR
- No clinical response (<MR) on a lenalidomide containing regimen An overall response rate of 25% or more will be acceptable, while an overall response of less than or equal to 16% will be considered unacceptable. Response will be assessed according to a modified International Working Group Uniform Response Criteria (Durie et al., 2006)
- Complete Response: Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and ⩽5% plasma cells in bone marrow
- Very Good Partial Response- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h
- Partial Response- ⩾50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ⩾90% or to <200 mg per 24 h.
Measured: On treatment portion of study is completed after 12 cycles (each cycle is 28 days in duration) and one month of follow up. Patients may be followed for up to two years after last dose of lenalidomide and vorinostat for disease status and survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- David Siegel, M.D., Ph.D, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502085
- Sponsor's protocol ID
- Pro00002580
- Acronym
- RZD
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2011
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.
PubMed 16855634
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Trial of Vorinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma Patients Refractory to Previous Lenalidomide Containing Regimens
- ClinicalTrials.gov ID
- NCT01502085
- Acronym / sponsor ID
- RZD / Pro00002580
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma lenalidomide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Posted 21 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple myeloma.
Detailed description
lenalidomide has been investigated in combination with both lenalidomide and bortezomib regimens. "Investigational" means that the drug is still being studied and that the study doctors are trying to find out more about it; such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating relapsed and/or refractory multiple myeloma.
Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental because the FDA has not approved this combination. Participants will receive 25mg of lenalidomide on days 1-21 every 28 days.
Vorinostat is a drug that interferes with the life sustaining functions of the tumor cells. It has already received regulatory approval by the U.S. Food and Drug Administration (FDA) for the treatment of T-cell non-Hodgkin's Lymphoma in the United States. The usage of vorinostat in Multiple Myeloma is experimental (investigational) and has not been approved by the FDA, but studies in combination with proteasome inhibitors (bortezomib) and immunomodulatory (lenalidomide) agents are ongoing. Participants will receive either 400mg of vorinostat on days 1-7 and 15-21 every 28 days.
Dexamethasone is a steroid that is known to cause cell death in multiple myeloma. Dexamethasone is FDA approved for the treatment of multiple myeloma and many other disease states. Participants will receive either Dexamethasone 40mg for those less than 75 years of age or 20mg for those aged 75 years and above on days 1, 8, 15 and 22 every 28 days In this research study the investigators are looking to evaluate the safety and efficacy of vorinostat when combined with lenalidomide and dexamethasone in treating relapsed and/or refractory multiple myeloma, refractory to lenalidomide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat, Lenalinomide, Dexamethasone | Experimental | Drug: Vorinostat, Lenalinomide and DexamethasoneVorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Bilirubin <2 x upper limit of normal
- ALT and AST <2.5 x upper limit of normal
- Serum creatinine <3.0 mg/dL
- ANC ≥1.0 x 109/L
Key exclusion criteria (18 listed)
- Subjects must not meet any of the following exclusion criteria to be eligible to enroll in this study:
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 |
|---|---|---|
| Vorinostat, Lenalinomide and DexamethasoneVorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above | Drug | Vorinostat, Lenalinomide, Dexamethasone |
Primary outcome
Overall Response Rate (PR or Better) of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed/Refractory MM Refractory to a Previous Lenalidomide Containing Regimen
Time frame: On treatment portion of study is completed after 12 cycles (each cycle is 28 days in duration) and one month of follow up. Patients may be followed for up to two years after last dose of lenalidomide and vorinostat for disease status and survival.
Defined as: 1. Progression on therapy OR within 60 days after the last dose of a lenalidomide containing regimen OR 2. No clinical response (<MR) on a lenalidomide containing regimen An overall response rate of 25% or more will be acceptable, while an overall response of less than or equal to 16% will be considered unacceptable. Response will be assessed according to a modified International Working Group Uniform Response Criteria (Durie et al., 2006) * Complete Response: Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and ⩽5% plasma cells in bone marrow * Very Good Partial Response- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h * Partial Response- ⩾50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ⩾90% or to <200 mg per 24 h.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16855634Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.
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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.
David Siegel, M.D., Ph.D principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vorinostat, Lenalinomide and Dexamethasone in people with Multiple Myeloma, run by Hackensack Meridian 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 22 inclusion and 18 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 3 Apr 2026. 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 21 Jan 2022). 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 (PR or Better) of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed/Refractory MM Refractory to a Previous Lenalidomide Containing Regimen (time frame: On treatment portion of study is completed after 12 cycles (each cycle is 28 days in duration) and one month of follow up. Patients may be followed for up to two years after last dose of lenalidomide and vorinostat for disease status and survival.). 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 NCT01502085, 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 3 Apr 2026.