Multiple MyelomaPhase 2ZLd_LdNCT01501370
Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy
A Phase 2 study testing Vorinostat, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Tiziana Marangon at 8 sites in Italy.
Trial summary
Histone deacetylase (HDAC) inhibitors represent a potential new class of antitumor agents. Vorinostat (suberoylanilide Hydroxamic acid, SAHA) inhibits the activity of all 11 known human class I and II HDACs. 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, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesItaly
- Study dates
- Jan 2012to Jan 2012
- Phase
- Phase 2
- 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
- Age ≥ 18 years.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal for 24 consecutive months or surgically sterilized or agree to continuous abstinence from heterosexual sexual contact or willing to use effective contraception for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy; female patients not pregnant or nursing; female with a negative pregnancy test.
- Male patient agrees to use an acceptable method for contraception during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy.
- Patient diagnosed with MM based on standard criteria, and has measurable disease (14,15), defined as follows:
Show all 30Show fewer
- Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein), and/or where applicable, urine light-chain excretion of > 200 mg/24 hours or involved free light chain (FLC) level > 10 mg/dl provided serum FLC ratio is abnormal;
- Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
- Patient receiving Lenalidomide maintenance therapy as part of first line treatment (concomitant use of prednisone is accepted) and has experienced a biochemical relapse, with evidence of progressive disease defined as increase of 25% from lowest response value in any one or more of the following: Serum M-component (absolute increase must be ≥ 0.5 g/100 ml) and/or Urine M-component (absolute increase must be ≥ 200 mg per 24 h); only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/l) (12).
- No evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically hypercalcemia (serum calcium ≥ 11.5 mg/100 ml) or renal insufficiency (serum creatinine > 1.73 mmol/l), or anemia (hemoglobin value of > 2 g/100 ml below the lower limit of normal or a hemoglobin value < 10 g/100 ml) or bone lesions (lytic lesions, severe osteopenia or pathologic fractures) (11).
- Patient has a Karnofsky performance status ≥ 60%.
- Patient has a life-expectancy > 3 months.
- Patient has not active infectious hepatitis type B or C and no known HIV infection.
- Patient has not to have congenital long QT syndrome or right bundle branch block + left anterior hemiblock (bifascicular block).
- Screening ECG with a QTc < 450 msec.
- Patient has not to take anti-arrhythmic drugs or other medicinal products which led to QT prolongation and cumulative high dose of anthracycline.
- Patient has not clinically significant illness that would, in the investigator's opinion, increase the patient's risk for toxicity.
- Patient has not a currently active malignancy, other than non melanoma skin cancer and carcinoma in situ of the cervix. Patients are not considered to have a currently active second malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years and are considered by their physicians to be at less than 30% risk of relapse.
- No history of allergic reactions attributed to study agents.
- No prior exposure to HDACi. Patients exposed to valproic acid could be eligible with a wash out period of at least 30 days.
- More than 30 days since prior class Ia, Ib and Ic antiarrhythmic medications.
- Patient has the following laboratory values within 28 days before baseline day 1 of the cycle 1:
- Platelets count ≥ 75 x 109/L
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
- Aspartate transaminase (AST), Alanine transaminase (ALT), total bilirubin: ≤ 2 x the upper limit of normal (ULN).
- Calculated or measured creatinine clearance: ≥ 20 mL/minute
- PT and PTT: ≤ 1.5 the ULN
- Serum potassium ≥ LLN
- Serum magnesium ≥ LLN
- Serum phosphorus ≥ LLN
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness or social situation that would prevent the subject from signing the informed consent form or limit the compliance with study medications and requirements.
- Pregnant or beast feeding females.
- Use of any other concomitant standard/experimental anti-myeloma drug or therapy.
- Known positive for HIV or active infectious hepatitis, type B or C.
- Known congenital long QT syndrome or right bundle branch block + left anterior hemiblock (bifascicular block).
- Screening ECG with a QTc > 450 msec.
Show all 11Show fewer
- Ongoing therapy with anti-arrhythmic drugs or other medicinal products which led to QT prolongation and cumulative high dose of anthracycline.
- Patient with currently active malignancy, other than non melanoma skin cancer and carcinoma in situ of the cervix. Patients are not considered to have a currently active second malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years and are considered by their physicians to be at less then 30% risk of relapse.
- History of allergic reactions attributed to study agents.
- Prior exposure to HDACi. Patients exposed to valproic acid could be eligible with a wash out period of at least 30 days.
- Less than 30 days since prior class Ia, Ib and Ic antiarrhythmic medications
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Clinica di Ematologia, A.O.U. Ospedali Riuniti, Ospedale Umberto I di Ancona
Ancona, Ancona, 60020
U.O.S. di Ematologia, Ospedale Mazzoni
Ascoli Piceno, Ascoli Piceno, 63100
Dh ematologia, A.O.U. Careggi
Florence, Firenze, 50139
Ematologia, Ospedale S. Maria della Misericordia
Perugia, Perugia, 06156
Ematologia e Immunoematologia, Azienda Ospedaliera Riuniti Marche Nord
Pesaro, Pesaro, 61100
Dip. Ematologia-U.O di Ematologia Generale-Azienda USL di Pescara-P.O. dello Spirito Santo
Pescara, Pescara, 65100
Ematologia , A.O.U. Pisana
Pisa, Pisa, 56126
Universitaria di Ematologia, A.O.U. San Giovanni Battista di Torino,
Torino, Torino, 10126
About this study
Official title: A Phase II, Multi-center, Open-label, Randomized Study of Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy
Histone deacetylase (HDAC) inhibitors represent a potential new class of antitumor agents. Vorinostat (suberoylanilide Hydroxamic acid, SAHA) inhibits the activity of all 11 known human class I and II HDACs. HDACs have many protein targets whose structure and function are altered by acetylation, including histones and non-histones proteins component of transcription factors controlling gene expression and proteins that regulate cell proliferation, migration and death (1). Vorinostat has undergone initial evaluation in several phase I and II clinical trials in both solid and hematologic malignancies. It has shown activity in hematologic malignancies including Hodgkin's disease and non Hodgkin's lymphomas (2-5); it has been approved for treatment of cutaneous manifestation in patients with primary cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies (6). HDAC function is critical for Multiple Myeloma (MM) cells by actively maintaining a transcriptional program indispensable for their uncontrolled proliferation and/or inappropriate resistance to pro-apoptotic stimuli. The pleiotropic anti-MM effects of Vorinostat and its ability to sensitize MM cellsto multiple conventional or novel agents (7) provide the framework for clinical trials of Vorinostat in MM. A phase I trial of oral Vorinostat alone in advanced MM shows modest activity, but treatment was generally well tolerated (common drug related adverse events (AEs) included fatigue, anorexia, dehydration, diarrhea and nausea and were mostly grade < 2) (8). A phase I clinical trial of Vorinostat in association with Bortezomib in relapsed MM patients report a partial response (PR) rate of 42%, with responses occurring also in patients refractory to a previous Bortezomib based regimen. Treatment was generally well tolerated (main adverse events were myelosuppression, fatigue and diarrhea) (9). Lenalidomide is an active agent against MM, that as shown activity in both the relapse and newly diagnosed settings, in combination with chemotherapy or steroids only. The dose of Lenalidomide commonly used in the relapse setting, in association with steroids, is 25 mg/day on days 1-21 every 28 days (10, 11). A recent phase I study evaluated the safety and tolerability of Vorinostat in combination with Lenalidomide and Dexamethasone in relapsed patients:no dose limiting toxicities prohibited dose escalation, the maximum tolerated dose has not been reached and the maximum administered dose was Lenalidomide 25 mg/day on days 1-21, Dexamethasone 40 mg/day on days 1,8,15,22, Vorinostat 400 mg/day on days 1-7 and 15-21; each cycle was repeated every 28 days. Rate of at least PR was 51%, and activity was seen also in patients who received prior Lenalidomide therapy (clinical benefit reported in 69% of patients, including minimal response or better in 33% of Lenalidomide refractory patients). The most common drug related grade > 3 AEs were neutropenia, thrombocytopenia, diarrhea, anemia and fatigue (12). Since Vorinostat has shown efficacy also in patients previously treated with Lenalidomide, and in patients refractory to Lenalidomide, the investigators hypothesis is that the addition of Vorinostat and low-dose dexamethasone to Lenalidomide (ZLd), in patients experiencing a biochemical relapse during a Lenalidomide maintenance ongoing therapy, can overcome Lenalidomide-drug resistance and result in a significant response rate, that can translate into a significant improvement in survival of MM patients. The second hypothesis is that, since the dose of Lenalidomide commonly administered in maintenance therapy, is 10 mg days 1-21 every 28 days, the increase in Lenalidomide dose to the standard dose used for relapsing patients, plus low-dose Dexamethasone (Ld), in patients experiencing a biochemical relapse during a Lenalidomide ongoing maintenance, can as well overcome Lenalidomide-drug resistance and determine a significant response rate, that can translate into a significant improvement in survival of MM patients.
This is a multicenter non comparative, randomized, open label, phase II study. Patients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive:
Read more
Cohort 1: ZLd association:
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.
Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
Cohort 2: Ld association:
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
Patients must have a -confirmed diagnosis of relapsed multiple myeloma. In this Phase II study, a total of up to 35 patients in the ZLd cohort and 48 in the Ld cohort will be enrolled. It is anticipated that full accrual to this study will take approximately 36 months.
- Conditions
- Multiple Myeloma
- Being tested
- Vorinostat, Lenalidomide, Dexamethasone
- Keywords
- Myeloma, Biochemical relapse
- 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.
VorinostatDrug
Also called Zolinza
Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle
LenalidomideDrug
Also called Revlimid
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
DexamethasoneDrug
Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
LenalidomideDrug
Also called Revlimid
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
DexamethasoneDrug
Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| ZLd | Experimental | Patients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive:
Cohort 1: ZLd association:
* Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
* Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.
* Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days. Receives: Drug: Vorinostat; Drug: Lenalidomide; Drug: Dexamethasone |
| Ld | Active comparator | Patients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive: Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
• Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days. Receives: Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PR (PARTIAL RESPONSE) with the association of ZLd and Ld
Determine the rate of PR with the association of ZLd and Ld in patients who experience biochemical relapse during Lenalidomide maintenance therapy. ZLd and Ld: responses will be evaluated after the enrollment of 10 and 18 pts respectively. If ≤1 and ≤2 respectively responses will be observed the trial will be stopped. Otherwise 19 and 25 pts respectively will be enrolled: if ≤5 for Zld and ≤7 for Ld responses will be observed, no further investigation will be needed
Measured: Responses will be evaluated after 112 days from enrollment of each patients (4 cycles of therapy)
Secondary outcomes (2)
duration of progression free survival
The occurrence of progression will determine the duration of PFS.
Measured: date of randomization to date of first documentation of progression from any cause, assessed every 3 months from removal of treatment, for approximately 2 years
Overall survival
The occurence of death will determine the OS
Measured: date of randomization to date of death from any cause, assessed every 3 months from removal of treatment, for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiziana Marangon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tiziana Marangon, University of Turin, Italy
- Investigators
- Antonio Palumbo, MD, Principal investigator, Division of Hematology, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501370
- Sponsor's protocol ID
- UNITO-MM-01
- Other IDs
- 2011-005931-17, RV-MM-PI-0706, MK-0683 -224-00
- Acronym
- ZLd_Ld
- Status last verified
- May 2016
- First submitted
- 16 Dec 2011
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Open-label, Randomized Study of Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy
- ClinicalTrials.gov ID
- NCT01501370
- Acronym / sponsor ID
- ZLd_Ld / UNITO-MM-01
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Biochemical relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tiziana MarangonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Dec 2011 (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.
Histone deacetylase (HDAC) inhibitors represent a potential new class of antitumor agents. Vorinostat (suberoylanilide Hydroxamic acid, SAHA) inhibits the activity of all 11 known human class I and II HDACs. HDACs have many protein targets whose structure and function are altered by acetylation, including histones and non-histones proteins component of transcription factors controlling gene expression and proteins that regulate cell proliferation, migration and death (1). Vorinostat has undergone initial evaluation in several phase I and II clinical trials in both solid and hematologic malignancies. It has shown activity in hematologic malignancies including Hodgkin's disease and non Hodgkin's lymphomas (2-5); it has been approved for treatment of cutaneous manifestation in patients with primary cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies (6). HDAC function is critical for Multiple Myeloma (MM) cells by actively maintaining a transcriptional program indispensable for their uncontrolled proliferation and/or inappropriate resistance to pro-apoptotic stimuli. The pleiotropic anti-MM effects of Vorinostat and its ability to sensitize MM cellsto multiple conventional or novel agents (7) provide the framework for clinical trials of Vorinostat in MM. A phase I trial of oral Vorinostat alone in advanced MM shows modest activity, but treatment was generally well tolerated (common drug related adverse events (AEs) included fatigue, anorexia, dehydration, diarrhea and nausea and were mostly grade < 2) (8). A phase I clinical trial of Vorinostat in association with Bortezomib in relapsed MM patients report a partial response (PR) rate of 42%, with responses occurring also in patients refractory to a previous Bortezomib based regimen. Treatment was generally well tolerated (main adverse events were myelosuppression, fatigue and diarrhea) (9). Lenalidomide is an active agent against MM, that as shown activity in both the relapse and newly diagnosed settings, in combination with chemotherapy or steroids only. The dose of Lenalidomide commonly used in the relapse setting, in association with steroids, is 25 mg/day on days 1-21 every 28 days (10, 11). A recent phase I study evaluated the safety and tolerability of Vorinostat in combination with Lenalidomide and Dexamethasone in relapsed patients:no dose limiting toxicities prohibited dose escalation, the maximum tolerated dose has not been reached and the maximum administered dose was Lenalidomide 25 mg/day on days 1-21, Dexamethasone 40 mg/day on days 1,8,15,22, Vorinostat 400 mg/day on days 1-7 and 15-21; each cycle was repeated every 28 days. Rate of at least PR was 51%, and activity was seen also in patients who received prior Lenalidomide therapy (clinical benefit reported in 69% of patients, including minimal response or better in 33% of Lenalidomide refractory patients). The most common drug related grade > 3 AEs were neutropenia, thrombocytopenia, diarrhea, anemia and fatigue (12). Since Vorinostat has shown efficacy also in patients previously treated with Lenalidomide, and in patients refractory to Lenalidomide, the investigators hypothesis is that the addition of Vorinostat and low-dose dexamethasone to Lenalidomide (ZLd), in patients experiencing a biochemical relapse during a Lenalidomide maintenance ongoing therapy, can overcome Lenalidomide-drug resistance and result in a significant response rate, that can translate into a significant improvement in survival of MM patients. The second hypothesis is that, since the dose of Lenalidomide commonly administered in maintenance therapy, is 10 mg days 1-21 every 28 days, the increase in Lenalidomide dose to the standard dose used for relapsing patients, plus low-dose Dexamethasone (Ld), in patients experiencing a biochemical relapse during a Lenalidomide ongoing maintenance, can as well overcome Lenalidomide-drug resistance and determine a significant response rate, that can translate into a significant improvement in survival of MM patients.
This is a multicenter non comparative, randomized, open label, phase II study. Patients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive:
Cohort 1: ZLd association:
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.
Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
Cohort 2: Ld association:
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
Patients must have a -confirmed diagnosis of relapsed multiple myeloma. In this Phase II study, a total of up to 35 patients in the ZLd cohort and 48 in the Ld cohort will be enrolled. It is anticipated that full accrual to this study will take approximately 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZLd | Experimental | Drug: Vorinostat, Drug: Lenalidomide, Drug: DexamethasonePatients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive: Cohort 1: ZLd association: * Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days * Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle. * Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days. |
| Ld | Active comparator | Drug: Lenalidomide, Drug: DexamethasonePatients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive: Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days • Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Age ≥ 18 years.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal for 24 consecutive months or surgically sterilized or agree to continuous abstinence from heterosexual sexual contact or willing to use effective contraception for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy; female patients not pregnant or nursing; female with a negative pregnancy test.
- Male patient agrees to use an acceptable method for contraception during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy.
Key exclusion criteria (11 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness or social situation that would prevent the subject from signing the informed consent form or limit the compliance with study medications and requirements.
- Pregnant or beast feeding females.
- Use of any other concomitant standard/experimental anti-myeloma drug or therapy.
- Known positive for HIV or active infectious hepatitis, type B or C.
- Known congenital long QT syndrome or right bundle branch block + left anterior hemiblock (bifascicular block).
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 |
|---|---|---|
| VorinostatAlso: ZolinzaVorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle | Drug | ZLd |
| LenalidomideAlso: RevlimidLenalidomide orally at the dose of 25 mg/day for 21 days every 28 days | Drug | ZLd |
| DexamethasoneDexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days. | Drug | ZLd |
| LenalidomideAlso: RevlimidLenalidomide orally at the dose of 25 mg/day for 21 days every 28 days | Drug | Ld |
| DexamethasoneDexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days. | Drug | Ld |
Primary outcome
Rate of PR (PARTIAL RESPONSE) with the association of ZLd and Ld
Time frame: Responses will be evaluated after 112 days from enrollment of each patients (4 cycles of therapy)
Determine the rate of PR with the association of ZLd and Ld in patients who experience biochemical relapse during Lenalidomide maintenance therapy. ZLd and Ld: responses will be evaluated after the enrollment of 10 and 18 pts respectively. If ≤1 and ≤2 respectively responses will be observed the trial will be stopped. Otherwise 19 and 25 pts respectively will be enrolled: if ≤5 for Zld and ≤7 for Ld responses will be observed, no further investigation will be needed
2 secondary outcomes
duration of progression free survival
Time frame: date of randomization to date of first documentation of progression from any cause, assessed every 3 months from removal of treatment, for approximately 2 years
Overall survival
Time frame: date of randomization to date of death from any cause, assessed every 3 months from removal of treatment, for approximately 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
Related trials for Multiple Myeloma
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 2
Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1/2
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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.
Antonio Palumbo, MD principal investigator
Division of Hematology, University of Turin, Italy
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vorinostat, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Tiziana Marangon at 8 sites in Italy.
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 30 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: withdrawn, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of PR (PARTIAL RESPONSE) with the association of ZLd and Ld (time frame: Responses will be evaluated after 112 days from enrollment of each patients (4 cycles of therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2016.