Relapsed or Refractory Multiple MyelomaPhase 2PERSPECTIVENCT02046915
Phase II Multicenter, Open-label, Single Arm Clinical Study of Pomalidomide and dexamethasonE and Cyclophosphamide
A Phase 2 study testing Imnovid (pomalidomide), Dexamethasone and Endoxan (Cyclophosphamide) in people with Relapsed or Refractory Multiple Myeloma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens combining novel agents and alkylating agents. However, in applying this approach the patients are at substantial risks of a critical myelosuppression. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Imnovid (pomalidomide), Dexamethasone and Endoxan (Cyclophosphamide)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to 17 Aug 2017
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥ 18 years at the time of signing the informed consent.
- Understand and voluntarily sign an informed consent prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours). In case of oligosecretory myeloma: involved FLC level ≥ 10 mg/dl, provided sFLC ratio is abnormal.
- Subjects must have had at least two prior anti-myeloma regimens (incl. bortezomib and lenalidomide) and must have been progressed under the last prior treatment. Induction therapy followed by ASCT and consolidation/ maintenance will be considered as one regimen.
- ECOG performance status score of 0, 1, or 2.
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- Females of childbearing potential (FCBP1) must agree:
- to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe, to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
- Males must agree: to use a condom during any sexual contact or practice complete abstinence from heterosexual contact with a pregnant female and a FCBP while participating in the study, during dose interruptions and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy, to refrain from donating semen or sperm while on Pomalidomide and for 28 days after discontinuation from this study treatment.
- All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
- All subjects must agree not to share medication.
Who cannot join
- -Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,000/μL.
- Subject with platelet count 30,000/µL are not eligible regardless of the percentage of plasma cells in the bone marrow. For subject with platelet count > 30,000/µL and < 75,000/µL, percentage of plasma cells in bone marrow should be 50%.
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L).
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted).
- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) except due to multiple myeloma.
- Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia.
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- GFR < 30 ml/min or patient requiring hemodialysis
- Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following:
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
- Previous therapy with Pomalidomide.
- Hypersensitivity to thalidomide, lenalidomide, or Dexamethasone (this includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).
- Peripheral neuropathy ≥ Grade 2.
- Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
- Subjects who are planning for or who are eligible for stem cell transplant.
- Subjects with any one of the following:
- Congestive heart failure (NY Heart Association Class III or IV)
- Myocardial infarction within 12 months prior to starting study treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
- Subjects who received any of the following within the last 14 days of initiation of study treatment:
- Major surgery (kyphoplasty is not considered major surgery)
- Use of any anti-myeloma drug therapy.
- Use of any investigational agents within 28 days or five half-lives (whichever is longer) of treatment.
- Incidence of gastrointestinal disease that may significantly alter the absorption of Pomalidomide.
- Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form.
- Pregnant or breastfeeding females.
- Known human immunodeficiency virus (HIV) positivity, active infectious hepatitis A, B or C or chronic hepatitis B or C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multicenter, Open-label, Single Arm Clinical Study of Pomalidomide and dexamethasonE in RelapSed Myeloma Plus rEsponse Adapted Cyclophosphamide as a Tailored InnoVativE Strategy
Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens combining novel agents and alkylating agents. However, in applying this approach the patients are at substantial risks of a critical myelosuppression. Pomalidomide demonstrates significant activity in combination with Dexamethasone in relapsed or refractory multiple myeloma. This trial is an attempt to further improve the efficacy of Pomalidomide/Dexamethasone as well as to balance efficacy and toxicity. Integration of Cyclophosphamide in the treatment in case of suboptimal response or first evidence of progressive disease has the aim to significantly increase duration of treatment that should have a positive impact on PFS. It is furthermore an attempt to optimize the potential of Pomalidomide in the antimyeloma efficacy. Based on the recent findings, that myeloma is a disease with a wide clonal heterogeneity, combination treatment in case of suboptimal myeloma control might lead to a more effective suppression especially of aggressive subclones and might reduce early resistance. In addition, with the goal of keeping the individual patient as long as possible under an effective IMiD treatment, the potential of the drug might be optimized according to the current view of maintenance treatment resulting ideally in an outgrowth of indolent clones in the bone marrow niche.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Imnovid (pomalidomide), Dexamethasone, Endoxan (Cyclophosphamide)
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imnovid (pomalidomide)Drug
Also called Pomalyst
DexamethasoneDrug
Endoxan (Cyclophosphamide)Drug
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide, Dexamethasone, Cyclophosphamide | Experimental | 1. Pomalidomide administered orally at the starting dose of 4 mg/day on Days 1-21 of a 28-day cycle
2. Low-dose Dexamethasone administered orally at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle
3. Cyclophosphamide administered intravenously 500 mg/m² on Days 1 and 15 of a 28-day cycle Receives: Drug: Imnovid (pomalidomide); Drug: Dexamethasone; Drug: Endoxan (Cyclophosphamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: two years
Secondary outcomes (1)
progression free survival of Pomalidomide in combination with low-dose Dexamethasone and intravenous Cyclophosphamide
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startApr 2014
- Primary completion17 Aug 2016
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046915
- Sponsor's protocol ID
- 2013-003678-29
- Acronym
- PERSPECTIVE
- Status last verified
- Oct 2016
- First submitted
- 22 Jan 2014
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Open-label, Single Arm Clinical Study of Pomalidomide and dexamethasonE in RelapSed Myeloma Plus rEsponse Adapted Cyclophosphamide as a Tailored InnoVativE Strategy
- ClinicalTrials.gov ID
- NCT02046915
- Acronym / sponsor ID
- PERSPECTIVE / 2013-003678-29
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 28 Jan 2014 (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.
Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens combining novel agents and alkylating agents. However, in applying this approach the patients are at substantial risks of a critical myelosuppression. Pomalidomide demonstrates significant activity in combination with Dexamethasone in relapsed or refractory multiple myeloma. This trial is an attempt to further improve the efficacy of Pomalidomide/Dexamethasone as well as to balance efficacy and toxicity. Integration of Cyclophosphamide in the treatment in case of suboptimal response or first evidence of progressive disease has the aim to significantly increase duration of treatment that should have a positive impact on PFS. It is furthermore an attempt to optimize the potential of Pomalidomide in the antimyeloma efficacy. Based on the recent findings, that myeloma is a disease with a wide clonal heterogeneity, combination treatment in case of suboptimal myeloma control might lead to a more effective suppression especially of aggressive subclones and might reduce early resistance. In addition, with the goal of keeping the individual patient as long as possible under an effective IMiD treatment, the potential of the drug might be optimized according to the current view of maintenance treatment resulting ideally in an outgrowth of indolent clones in the bone marrow niche.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide, Dexamethasone, Cyclophosphamide | Experimental | Drug: Imnovid (pomalidomide), Drug: Dexamethasone, Drug: Endoxan (Cyclophosphamide)1. Pomalidomide administered orally at the starting dose of 4 mg/day on Days 1-21 of a 28-day cycle 2. Low-dose Dexamethasone administered orally at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle 3. Cyclophosphamide administered intravenously 500 mg/m² on Days 1 and 15 of a 28-day cycle |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must be ≥ 18 years at the time of signing the informed consent.
- Understand and voluntarily sign an informed consent prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours). In case of oligosecretory myeloma: involved FLC level ≥ 10 mg/dl, provided sFLC ratio is abnormal.
- Subjects must have had at least two prior anti-myeloma regimens (incl. bortezomib and lenalidomide) and must have been progressed under the last prior treatment. Induction therapy followed by ASCT and consolidation/ maintenance will be considered as one regimen.
Key exclusion criteria (29 listed)
- -Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,000/μL.
- Subject with platelet count 30,000/µL are not eligible regardless of the percentage of plasma cells in the bone marrow. For subject with platelet count > 30,000/µL and < 75,000/µL, percentage of plasma cells in bone marrow should be 50%.
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L).
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted).
- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) except due to multiple myeloma.
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 |
|---|---|---|
| Imnovid (pomalidomide)Also: Pomalyst | Drug | Pomalidomide, Dexamethasone, Cyclophosphamide |
| Dexamethasone | Drug | Pomalidomide, Dexamethasone, Cyclophosphamide |
| Endoxan (Cyclophosphamide) | Drug | Pomalidomide, Dexamethasone, Cyclophosphamide |
Primary outcome
response rate
Time frame: two years
1 secondary outcome
progression free survival of Pomalidomide in combination with low-dose Dexamethasone and intravenous Cyclophosphamide
Time frame: two 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 30 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Imnovid (pomalidomide), Dexamethasone and Endoxan (Cyclophosphamide) in people with Relapsed or Refractory Multiple Myeloma, run by University Hospital Tuebingen at 1 site in Germany.
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 11 inclusion and 29 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 30 Oct 2017. 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 Germany. 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 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?
response rate (time frame: two years). 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 30 Oct 2017.