Multiple MyelomaPhase 2POCODEXNCT04243109
Study of Pomalidomide, Oral Dexamethasone and Very Low-dose Cyclophosphamide in Patients With Refractory Multiple Myeloma Who Have Received Lenalidomide and Bortezomib
A Phase 2 study testing Pomalidomide + Cyclophosphamide + Dexamethasone in people with Multiple Myeloma, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Clinical trial with a pharmaceutical specialty in a new combination. Pomalidomide in combination with dexamethasone is indicated in the treatment of adult patients with multiple treatment-resistant or relapsing myeloma who have received at least two previous treatments, including lenalidomide and bortezomib, and who… 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?
- Pomalidomide + Cyclophosphamide + Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2017to 7 May 2019
- 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
- Patient over 18 years of age and who meets criteria 2 and / or 3.
- Patient diagnosed with symptomatic Multiple Myeloma according to standard criteria.
- Patients with symptomatic multiple myeloma in relapse / refractory after having received treatment with at least two cycles that include Bortezomib and with at least two cycles that include Lenalidomide, whether combined in the same therapeutic scheme or as part of different chemotherapy schemes.
- Patients with MM with measurable disease, defined as the presence of monoclonal component of at least 0.5 g / dL in serum or at least 0.2 g / d in urine, or in those without measurable disease the presence of altered light chain radius at the time of entry into the study.
- Patients with good general condition defined as ECOG ≤ 2.
- The patient must understand the written informed consent and sign it of his own accord.
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- The patient must be able to meet all scheduled visits and other requirements.
- Laboratory Criteria: Patients must present the following counts:Absolute neutrophils: ≥1000 / μL, Platelet Count: ≥50,000 / μL, Hemoglobin:> 8 gr / dL, Total bilirubin: <2 x upper limit of normal, AST and ALT: <3 x Upper limit of normal, Serum potassium: within the limits of normality.
- Women of childbearing age should have a negative pregnancy test.
- The male patient included in the trial must commit to always use a latex condom during any sexual contact with women of childbearing age, even if they have undergone a successful vasectomy.
Who cannot join
- Any concomitant disease, laboratory alteration or psychiatric disorder that may presuppose the subject's inability to sign the IC.
- PS> 3 according to the ECOG scale.
- Previous history of non-hematologic malignancies, unless the patient has been free of the disease for ≥ 5 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast.
- Patients who are unable or unwilling to undergo antithrombotic therapy.
- Known positive serology for human immunodeficiency virus HIV or active infectious hepatitis, type B, or C.
- Depressed heart function, or clinically significant heart disease
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- Severe hypercalcemia
- Major surgical interventions within 15 days prior to inclusion or not having recovered from their side effects.
- Any serious medical condition, including laboratory alterations that cause the patient to take an unacceptable risk if participating in this study or that may interfere with the interpretation of the study data.
- Patients treated with any investigational drug in the previous 28 days.
- Any severe medical condition, abnormality in laboratory tests or any psychiatric illness that prevents the signing of written consent.
- Pregnant or breastfeeding women.
- Known hypersensitivity to drugs or compounds of biological or chemical composition similar to those of the study.
- Plasma Cell Leukemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study (Phase II) of Pomalidomide, Oral Dexamethasone and Very Low-dose Cyclophosphamide in Patients With Refractory Multiple Myeloma Who Have Received Lenalidomide and Bortezomib
Clinical trial with a pharmaceutical specialty in a new combination.
Pomalidomide in combination with dexamethasone is indicated in the treatment of adult patients with multiple treatment-resistant or relapsing myeloma who have received at least two previous treatments, including lenalidomide and bortezomib, and who have experienced a disease progression in the last treatment.
The combination of Pomalidomide with Cyclophosphamide at metronomic doses (Very low doses) and Dexamethasone is tested in this clinical situation.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide + Cyclophosphamide + Dexamethasone
- Keywords
- Multiple Myeloma, Pomalidomide, Cyclophosphamide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide + Cyclophosphamide + DexamethasoneDrug
Treatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles:
- Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. Dose reductions will be made based on the evaluation of hematological and non-hematological toxicity.
- Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles.
- Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. In patients older than 75 years the dose will be reduced to 20 mg / day in the same previous schedule.
Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained.
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide + Cyclophosphamide + Dexamethasone | Experimental | Treatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles:
* Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started.
* Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles.
* Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles.
Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained. Receives: Drug: Pomalidomide + Cyclophosphamide + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best response
Evaluate the best response rate based on the criteria of the International Myeloma Working Group of the following responses at the end of each cycle or during the maintenance period.
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Secondary outcomes (9)
Time to Response
From the entry into the study or the start of treatment until the first evidence of a confirmed response.
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Duration of Response
Time from the first evidence of response to the progression or recurrence of the disease.
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Time to Progression
From the entry into the study or the start of treatment to the progression or recurrence of the disease.
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Global Survival
from the entry into the study or the start of treatment until the date of death of the patient or the last date on which it was known that the patient was alive.
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Progression Free Survival
from the entry into the study or the start of treatment to the progression or recurrence of the disease (includes death from myeloma)
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Tolerability of the study medication
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Measured: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Angiogenesis markers of metronomic chemotherapy activity
Evaluations of treatment of Circulating Endothelial Cells by multiparameter flow cytometry.
Measured: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Angiogenesis markers of metronomic chemotherapy activity 2
Evaluations of treatment of Circulating Endothelial Cells by serum levels of VEGF, TSP1.
Measured: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Immune system evaluation of metronomic chemotherapy activity
Evaluation of the Immune system by the determination of regulatory T populations.
Measured: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start23 Feb 2017
- Primary completion7 May 2019
- Study completion7 May 2019
Why it stopped: Low recruitment rate. Lack of interest of the sponsor.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Ángel Álvarez Rivas, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243109
- Sponsor's protocol ID
- FCO-PDC-2015-01
- Acronym
- POCODEX
- Status last verified
- Jan 2020
- First submitted
- 11 Nov 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be available. Individual participant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices) The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study (Phase II) of Pomalidomide, Oral Dexamethasone and Very Low-dose Cyclophosphamide in Patients With Refractory Multiple Myeloma Who Have Received Lenalidomide and Bortezomib
- ClinicalTrials.gov ID
- NCT04243109
- Acronym / sponsor ID
- POCODEX / FCO-PDC-2015-01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Pomalidomide, Cyclophosphamide, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate. Lack of interest of the sponsor.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 28 Jan 2020 (actual)
- 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.
Clinical trial with a pharmaceutical specialty in a new combination.
Pomalidomide in combination with dexamethasone is indicated in the treatment of adult patients with multiple treatment-resistant or relapsing myeloma who have received at least two previous treatments, including lenalidomide and bortezomib, and who have experienced a disease progression in the last treatment.
The combination of Pomalidomide with Cyclophosphamide at metronomic doses (Very low doses) and Dexamethasone is tested in this clinical situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide + Cyclophosphamide + Dexamethasone | Experimental | Drug: Pomalidomide + Cyclophosphamide + DexamethasoneTreatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles: * Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. * Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles. * Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient over 18 years of age and who meets criteria 2 and / or 3.
- Patient diagnosed with symptomatic Multiple Myeloma according to standard criteria.
- Patients with symptomatic multiple myeloma in relapse / refractory after having received treatment with at least two cycles that include Bortezomib and with at least two cycles that include Lenalidomide, whether combined in the same therapeutic scheme or as part of different chemotherapy schemes.
- Patients with MM with measurable disease, defined as the presence of monoclonal component of at least 0.5 g / dL in serum or at least 0.2 g / d in urine, or in those without measurable disease the presence of altered light chain radius at the time of entry into the study.
- Patients with good general condition defined as ECOG ≤ 2.
Key exclusion criteria (14 listed)
- Any concomitant disease, laboratory alteration or psychiatric disorder that may presuppose the subject's inability to sign the IC.
- PS> 3 according to the ECOG scale.
- Previous history of non-hematologic malignancies, unless the patient has been free of the disease for ≥ 5 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast.
- Patients who are unable or unwilling to undergo antithrombotic therapy.
- Known positive serology for human immunodeficiency virus HIV or active infectious hepatitis, type B, or C.
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 |
|---|---|---|
| Pomalidomide + Cyclophosphamide + DexamethasoneTreatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles: * Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. Dose reductions will be made based on the evaluation of hematological and non-hematological toxicity. * Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles. * Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. In patients older than 75 years the dose will be reduced to 20 mg / day in the same previous schedule. Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained. | Drug | Pomalidomide + Cyclophosphamide + Dexamethasone |
Primary outcome
Best response
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Evaluate the best response rate based on the criteria of the International Myeloma Working Group of the following responses at the end of each cycle or during the maintenance period.
9 secondary outcomes
Time to Response
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Duration of Response
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Time to Progression
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Global Survival
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Progression Free Survival
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Tolerability of the study medication
Time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.
Angiogenesis markers of metronomic chemotherapy activity
Time frame: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Angiogenesis markers of metronomic chemotherapy activity 2
Time frame: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Immune system evaluation of metronomic chemotherapy activity
Time frame: At baseline and before the beginning of the 2nd, 4th, 6th and 8th treatment cycle (each cycle is 28 days)
Results and safety
The study was stopped early (reason given: Low recruitment rate. Lack of interest of the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Yes. The individual participant data will be available. Individual participant data that underlie the results reportes in this article, after deidenttification (text, tables, figures and appendices) The other documents that will be available: study protocol, Statistical Analysis Plan, Informed Consent Form. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.
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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.
Miguel Ángel Álvarez Rivas, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pomalidomide + Cyclophosphamide + Dexamethasone in people with Multiple Myeloma, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 10 inclusion and 14 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 28 Jan 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 Spain. 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 stopped early (reason given: Low recruitment rate. Lack of interest of the sponsor.). Results are not available in the source record.
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?
Best response (time frame: Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.). 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 28 Jan 2020.