Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00772915
Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing dexamethasone and lenalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- dexamethasone and lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2008to 27 Jun 2018
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Newly diagnosed multiple myeloma, meeting the following criteria:
- Symptomatic disease
- Previously untreated disease
- Measurable or evaluable disease, defined by ≥ 1 of the following:
- Serum monoclonal protein ≥ 1.0 g/dL
- Monoclonal protein > 200 mg by 24-hour urine electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa:lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
- Measurable soft tissue plasmacytoma, not previously radiated
- No monoclonal gammopathy of unknown significance or asymptomatic myeloma
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain)
- ANC ≥ 1,500/μL
- Platelet count ≥ 75,000/μL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective forms of contraception 28 days prior to, during and 28 days after study treatment
- Registered into the RevAssist® program and willing to comply with program requirements
- Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight heparin
- Willing to provide mandatory blood and bone marrow samples
- Willing to return for follow up
- No uncontrolled infection
- No NYHA class III or IV heart failure
- No active deep vein thrombosis that has not been therapeutically anticoagulated
- No known hypersensitivity to thalidomide
- No known HIV positivity
- No known hepatitis type A, B, or C infection
- No other prior active malignancy within the past 2 years, except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy for solitary plasmacytoma
- More than 28 days since other prior experimental drug or therapy
- Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed
- No prior lenalidomide
- No prior cytotoxic chemotherapy
- No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease
- Prior corticosteroid for nonmalignant disease allowed
- Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent)
- Concurrent palliative radiotherapy for bone pain or fracture allowed
- No other concurrent anticancer agents or treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma
RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- To assess the progression-free survival at 1 year in patients with newly diagnosed symptomatic multiple myeloma treated with lenalidomide alone or in combination with dexamethasone added for disease progression or lack or partial response.
Secondary
- To assess the response rate of this regimen in these patients.
- To assess the toxicity of this regimen in these patients.
Tertiary
- To examine the effect of lenalidomide alone on tumor specific immunity and global parameters of immune function.
- To examine the effect of dexamethasone addition in patients requiring steroids.
- To correlate changes in parameters of immune response and measures of disease response.
- To examine the antiangiogenic activity of lenalidomide alone and in combination with dexamethasone.
- To examine the effect of lenalidomide alone on tumor cell survival and proliferation.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of second disease progression or unacceptable toxicity. Beginning in course 4, patients experiencing stable or progressive disease also receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all subsequent courses.
Blood and bone marrow samples are collected periodically for pharmacological and correlative studies. Samples are analyzed for parameters of immune activation, cell proliferation and apoptosis, and circulating tumor cells and endothelial cells via flow cytometry; global impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via CD34 staining.
After completion of study therapy, patients are followed periodically for up to 2 years.
- Being tested
- dexamethasone, lenalidomide
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- 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.
dexamethasoneDrug
Dose: -40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression.
If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle.
If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly.
lenalidomideDrug
25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described).
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide with On-Demand Dexamethasone | Experimental | Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression. Receives: Drug: dexamethasone; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Rate at 12 Months
PFS rate at 12 months is defined as the percentage of participants who are alive and progression-free at 12 months. Progression is exclusively defined as a patient with progressive disease while receiving treatment with lenalidomide in combination with dexamethasone. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in:
- Serum M-component (absolute increase >= 0.5g/dl)
- Urine M-component (absolute increase >= 200mg/24hour
- Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
- Bone marrow plasma cell percentage (absolute increase of >=10%)
Measured: 12 months from registration
Secondary outcomes (4)
Confirmed Response Rate
Confirmed response rate is defined as the percentage of participants who achieved a response that was confirmed on 2 consecutive evaluations during treatment
- Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& <5% plasma cells in bone marrow (BM)
- Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
- Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
Measured: Up to 18 cycles from registration
Overall Survival (OS)
OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method
Measured: Time from registration to death (up to 3 years)
Progression-free Survival (PFS)
PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.
Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:
- Serum M-component (absolute increase >= 0.5g/dl)
- Urine M-component (absolute increase >= 200mg/24hour
- Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
- Bone marrow plasma cell percentage (absolute increase of >=10%)
Measured: Time from registration to progression or death (up to 3 years)
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)
The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below.
Measured: Duration on treatment (up to 18 cycles from registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study start3 Dec 2008
- Primary completion22 Mar 2011
- Study completion27 Jun 2018
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 Multiple Myeloma and Plasma Cell NeoplasmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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 K. Kumar, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772915
- Sponsor's protocol ID
- CDR0000616057
- Other IDs
- P30CA015083, MC0884, 08-002093, NCI-2009-01201, RV-MM-PI-367
- Status last verified
- Jun 2018
- First submitted
- 12 Oct 2008
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00772915
- Acronym / sponsor ID
- CDR0000616057
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Dec 2008 (actual)
- Primary completion
- 22 Mar 2011 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 8 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- To assess the progression-free survival at 1 year in patients with newly diagnosed symptomatic multiple myeloma treated with lenalidomide alone or in combination with dexamethasone added for disease progression or lack or partial response.
Secondary
- To assess the response rate of this regimen in these patients.
- To assess the toxicity of this regimen in these patients.
Tertiary
- To examine the effect of lenalidomide alone on tumor specific immunity and global parameters of immune function.
- To examine the effect of dexamethasone addition in patients requiring steroids.
- To correlate changes in parameters of immune response and measures of disease response.
- To examine the antiangiogenic activity of lenalidomide alone and in combination with dexamethasone.
- To examine the effect of lenalidomide alone on tumor cell survival and proliferation.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of second disease progression or unacceptable toxicity. Beginning in course 4, patients experiencing stable or progressive disease also receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all subsequent courses.
Blood and bone marrow samples are collected periodically for pharmacological and correlative studies. Samples are analyzed for parameters of immune activation, cell proliferation and apoptosis, and circulating tumor cells and endothelial cells via flow cytometry; global impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via CD34 staining.
After completion of study therapy, patients are followed periodically for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide with On-Demand Dexamethasone | Experimental | Drug: dexamethasone, Drug: lenalidomideLenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| dexamethasoneDose: -40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression. If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle. If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly. | Drug | Lenalidomide with On-Demand Dexamethasone |
| lenalidomide25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described). | Drug | Lenalidomide with On-Demand Dexamethasone |
Primary outcome
Progression-free Survival (PFS) Rate at 12 Months
Time frame: 12 months from registration
PFS rate at 12 months is defined as the percentage of participants who are alive and progression-free at 12 months. Progression is exclusively defined as a patient with progressive disease while receiving treatment with lenalidomide in combination with dexamethasone. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase >= 0.5g/dl) * Urine M-component (absolute increase >= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl * Bone marrow plasma cell percentage (absolute increase of >=10%)
4 secondary outcomes
Confirmed Response Rate
Time frame: Up to 18 cycles from registration
Overall Survival (OS)
Time frame: Time from registration to death (up to 3 years)
Progression-free Survival (PFS)
Time frame: Time from registration to progression or death (up to 3 years)
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)
Time frame: Duration on treatment (up to 18 cycles from registration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- 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 K. Kumar, MD study chair
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 and lenalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, 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?
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 18 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 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 8 Aug 2012). 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?
Progression-free Survival (PFS) Rate at 12 Months (time frame: 12 months from registration). 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 18 Jan 2020.