Recurrent Plasma Cell MyelomaPhase 2NCT01794039
Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide
A Phase 2 study testing Dexamethasone, Lenalidomide and Pomalidomide in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by Mayo Clinic at 1 site in United States.
Trial summary
This randomized phase II trial studies how well pomalidomide and dexamethasone work compared to lenalidomide and dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) or did not respond to previous treatment with lenalidomide (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- What is being tested?
- Dexamethasone, Lenalidomide and Pomalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2016
- Phase
- Phase 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
- Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula
- Absolute neutrophil count >= 1000uL
- (Untransfused) platelet count >= 50000/uL
- Hemoglobin >= 8.0 g/dL
- Relapsed myeloma that previously became refractory to lenalidomide, after initial response of partial response or better to the drug; refractory is defined as progression on treatment with a dose of at least 10 mg daily for lenalidomide; greater than or equal to 180 days must have elapsed since previous lenalidomide therapy was stopped
- Measurable disease of multiple myeloma as defined by at least ONE of the following:
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- Serum monoclonal protein >= 1.0 g/dL
- >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Previously treated; NOTE: no limit to prior therapy provided there is adequate residual organ function
- Provide informed written consent
- Females of childbearing potential (FCBP)* must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid Risk Evaluation and Mitigation Strategy [REMS]), and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all study participants must be registered into the Revlimid REMS program, and be willing and able to comply with the requirements of Revlimid REMS program
- A female of childbearing potential is a sexually mature woman 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)
- Willing to return to Mayo Clinic enrolling institution for follow-up
Who cannot join
- Residual toxicity of > grade 1 from prior therapy
- Other active malignancy < 1 year prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
- Any of the following:
- Pregnant women
- Nursing women (lactating females must agree not to breast feed while taking lenalidomide)
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
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- Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- New York Heart Association classification III or IV
- Diagnosed active deep vein thrombosis (DVT) that has not been therapeutically anticoagulated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase 2 Trial of Retreatment With Pomalidomide or Lenalidomide With Dexamethasone for Patients With Relapsed Myeloma
This randomized phase II trial studies how well pomalidomide and dexamethasone work compared to lenalidomide and dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) or did not respond to previous treatment with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system kill cancer cells and may also prevent the growth of new blood vessels that tumors need to grow. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work better by making cancer cells more sensitive to the drugs. It is not yet known whether pomalidomide and dexamethasone or lenalidomide and dexamethasone are effective in treating patients with relapsed or refractory multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the confirmed response rate of the combination of lenalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm A) II. To assess the confirmed response rate of the combination of pomalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm B)
SECONDARY OBJECTIVES:
- To assess the toxicity in each arm in patients with relapsed myeloma who have previously received lenalidomide.
II. To assess the response rates with pomalidomide and dexamethasone in patients relapsing on lenalidomide and dexamethasone. (Arm A) III. To assess time to progression and overall survival with each approach.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive lenalidomide orally (PO) daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.
ARM B: Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
- Being tested
- Dexamethasone, Lenalidomide, Pomalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given PO
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
PomalidomideDrug
Also called 4-Aminothalidomide, Actimid, CC-4047, Pomalyst
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (lenalidomide, dexamethasone) | Experimental | Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. Receives: Drug: Dexamethasone; Drug: Lenalidomide |
| Arm B (pomalidomide, dexamethasone) | Experimental | Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Dexamethasone; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Measured: Up to 2 years
Secondary outcomes (3)
Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.
Measured: Up to 30 days after last day of study drug treatment
Overall Survival
The distribution of survival time will be estimated using the method of Kaplan-Meier. Due to an early closer from slow accrual the data from both arms was combined in survival analysis.
Measured: Time from registration to death due to any cause, assessed up to 2 years
Time to Progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier. The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Measured: Time from registration to the earliest date with documentation of disease progression, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2016
- Study completionNov 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.
- Other trials for Recurrent Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shaji Kumar, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794039
- Sponsor's protocol ID
- MC1187
- Other IDs
- NCI-2013-00412, 12-006426, MCCC Add 1, MC1187, P30CA015083
- Status last verified
- Aug 2018
- First submitted
- 14 Feb 2013
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Trial of Retreatment With Pomalidomide or Lenalidomide With Dexamethasone for Patients With Relapsed Myeloma
- ClinicalTrials.gov ID
- NCT01794039
- Acronym / sponsor ID
- MC1187
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well pomalidomide and dexamethasone work compared to lenalidomide and dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) or did not respond to previous treatment with lenalidomide (refractory). Pomalidomide and lenalidomide may help the immune system kill cancer cells and may also prevent the growth of new blood vessels that tumors need to grow. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone may also help pomalidomide and lenalidomide work better by making cancer cells more sensitive to the drugs. It is not yet known whether pomalidomide and dexamethasone or lenalidomide and dexamethasone are effective in treating patients with relapsed or refractory multiple myeloma.
Detailed description
PRIMARY OBJECTIVES:
- To assess the confirmed response rate of the combination of lenalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm A) II. To assess the confirmed response rate of the combination of pomalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm B)
SECONDARY OBJECTIVES:
- To assess the toxicity in each arm in patients with relapsed myeloma who have previously received lenalidomide.
II. To assess the response rates with pomalidomide and dexamethasone in patients relapsing on lenalidomide and dexamethasone. (Arm A) III. To assess time to progression and overall survival with each approach.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive lenalidomide orally (PO) daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.
ARM B: Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (lenalidomide, dexamethasone) | Experimental | Drug: Dexamethasone, Drug: LenalidomidePatients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. |
| Arm B (pomalidomide, dexamethasone) | Experimental | Drug: Dexamethasone, Drug: PomalidomidePatients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula
- Absolute neutrophil count >= 1000uL
- (Untransfused) platelet count >= 50000/uL
- Hemoglobin >= 8.0 g/dL
- Relapsed myeloma that previously became refractory to lenalidomide, after initial response of partial response or better to the drug; refractory is defined as progression on treatment with a dose of at least 10 mg daily for lenalidomide; greater than or equal to 180 days must have elapsed since previous lenalidomide therapy was stopped
Key exclusion criteria (10 listed)
- Residual toxicity of > grade 1 from prior therapy
- Other active malignancy < 1 year prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
- Any of the following:
- Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
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 |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO | Drug | Arm A (lenalidomide, dexamethasone), Arm B (pomalidomide, dexamethasone) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Arm A (lenalidomide, dexamethasone) |
| PomalidomideAlso: 4-Aminothalidomide, Actimid, CC-4047, PomalystGiven PO | Drug | Arm B (pomalidomide, dexamethasone) |
Primary outcome
Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
Time frame: Up to 2 years
The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
3 secondary outcomes
Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 30 days after last day of study drug treatment
Overall Survival
Time frame: Time from registration to death due to any cause, assessed up to 2 years
Time to Progression
Time frame: Time from registration to the earliest date with documentation of disease progression, assessed up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shaji Kumar principal investigator
Mayo Clinic
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 Dexamethasone, Lenalidomide and Pomalidomide in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by Mayo Clinic 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 16 inclusion and 10 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Aug 2018). 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?
Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations (time frame: Up to 2 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 21 Aug 2018.