Multiple MyelomaPhase 1/2PrE1003NCT00790842
Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction
A Phase 1/2 study testing Lenalidomide, Dexamethasone and Anticoagulants in people with Multiple Myeloma and Plasma Cell Neoplasm, run by PrECOG, LLC. at 16 sites in United States.
Trial summary
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Neoplasm
- What is being tested?
- Lenalidomide, Dexamethasone and Anticoagulants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 16 sitesUnited States
- Study dates
- 21 Jan 2009to 8 Mar 2018
- Phase
- Phase 1/2
- 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
- Diagnosed with previously treated multiple myeloma.
- Measurable disease assessed by one of the following ≤21 days prior to registration:
- Serum monoclonal protein ≥1 g by protein electrophoresis
- Urine monoclonal protein >200 mg 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)
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- If both serum and urine m-components are present, both must be followed in order to evaluate response.
- All previous cancer therapy including chemotherapy, radiation, hormonal therapy and surgery, must be discontinued ≥2 weeks prior to registration.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Acceptable organ and marrow function ≤21 days prior to registration:
- Absolute neutrophil count (ANC) ≥1000/mm³
- Platelet count ≥75,000/mm³
- Total bilirubin ≤2 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal
- Renal impairment at baseline as measured by serum creatinine clearance (CrCl) ≤60 mL/min ≤21 days prior to registration.
- Females of Childbearing Potential (FCBP) must have a negative pregnancy test within 10-14 days and again within 24 hours of starting Cycle 1 and must use an effective double-method contraception for ≥28 days prior to, during, and for ≥28 days after completion of study therapy.
- Able to take required prophylactic anticoagulation.
- Able to understand and willingness to sign a written informed consent.
- Willing to provide blood samples for research purposes (Mayo Clinic sites only).
- If previously received lenalidomide, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥6 months from start of that therapy.
Who cannot join
- Concurrent use of other anti-cancer agents or treatments. Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.
- Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection requiring IV antibiotics
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Uncontrolled cardiac arrhythmia
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- Psychiatric illness/social situation that would limit compliance with study requirements.
- Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Breast-feeding women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.
- HIV-positive patients on combination antiretroviral therapy.
- Known hypersensitivity to thalidomide or other immunomodulatory drugs.
- History of Stevens-Johnson syndrome characterized by a desquamating rash while taking thalidomide or similar drugs.
- Other active malignancy except for non melanoma skin cancer or in situ cervical or breast cancer.
- Concurrent radiation therapy, except for palliation of a single painful bone lesion or fracture.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
McFarland Clinic
Ames, Iowa, 50010
Michigan Cancer Research Consortium and Oncology Research- St. Joseph Mercy Hospital - Ann Arbor
Ann Arbor, Michigan, 48106-0955
Emory University Winship Cancer
Atlanta, Georgia, 30322
University of IL at Chicago
Chicago, Illinois, 60612
Kinston Medical Specialists
Kinston, North Carolina, 28501
Gundersen Lutheran
La Crosse, Wisconsin, 54601
WVU Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Mayo Clinic
Rochester, Minnesota, 55905
Metro MN CCOP
Saint Louis Park, Minnesota, 55416
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259-5499
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101
Waukesha Memorial Hospital (ProHealth Care)
Waukesha, Wisconsin, 53188
Aurora Cancer Center
Wauwatosa, Wisconsin, 53226
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
About this study
Official title: A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.
Read the detailed description
Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed. Several novel agents for MM have now become available including the immunomodulatory drugs thalidomide, lenalidomide, as well as the proteasome inhibitor, bortezomib. Each of these agents is undergoing extensive clinical evaluation in combination with other therapies to produce unprecedented response rates in newly diagnosed and relapsed MM. Lenalidomide has proven to be a highly effective treatment agent, particularly when used in combination with dexamethasone but is renally excreted and little information is available about its use in myeloma patients with impaired kidney function (20% have renal failure at some time after diagnosis). Defining a safe and effective dose of lenalidomide to use is a critical step in MM treatment.
OUTLINE: This is a Phase I, dose-escalation study of lenalidomide followed by a Phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-60 mL/min] vs severe [creatinine clearance <30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance <30 mL/min and requires dialysis]).
Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone 40 mg on days 1, 8, 15, and 22. There is a 7 day rest (days 22-28) from lenalidomide. Each cycle is 28 days and repeated in the absence of disease progression or unacceptable toxicity.
Patients enrolled in the phase II portion of the study will undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide (Mayo Clinic sites only).
After completion of study treatment, patients are followed every 6 months for up to 3 years.
- Conditions
- Multiple Myeloma, Plasma Cell Neoplasm
- Being tested
- Lenalidomide, Dexamethasone, Anticoagulants
- Keywords
- Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Multiple Myeloma with Renal Dysfunction, 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.
LenalidomideDrug
Also called Revlimid
Given by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity.
DexamethasoneDrug
Also called Decadron
40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity.
AnticoagulantsDrug
Also called Aspirin, Heparin, Low Molecular Weight Heparin, Coumadin
Anticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
| Study group | Role | What they receive |
|---|---|---|
| Group A - CrCl 30-60 mL/min | Experimental | Creatinine clearance 30 - 60 mL/min, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. Receives: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Anticoagulants |
| Group B, CrCl < 30 mL/min | Experimental | Creatinine clearance < 30 mL/min, not on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. Receives: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Anticoagulants |
| Group C, CrCl < 30 mL/min, on dialysis | Experimental | Creatinine clearance < 30 mL/min and on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. Receives: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Anticoagulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:
- Grade 3 or higher neutropenia with fever ≥38.5 degrees C
- Grade 4 neutropenia ≥7 days
- Grade 4 or higher thrombocytopenia
- Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
Measured: First cycle of therapy (28 days)
Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components
Measured: 56 months
Secondary outcomes (6)
Overall Survival Time
Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
Measured: 56 months
Duration of Response
Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.
Measured: 56 months
Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
Measured: 56 months
Renal Function Over Time
To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.
Measured: 56 months
Pharmacokinetics of Lenalidomide in Impaired Renal Function
To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only).
Measured: 56 months
Progression-free Survival
Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.
Measured: 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study start21 Jan 2009
- Primary completion30 Sep 2017
- Study completion8 Mar 2018
Why it stopped: Slow enrollment
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- PrECOG, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Joseph R. Mikhael, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790842
- Sponsor's protocol ID
- PrE1003
- Other IDs
- RV-MM-PrECOG-0394
- Acronym
- PrE1003
- Status last verified
- Sep 2018
- First submitted
- 13 Nov 2008
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is proprietary.
Publications
Mikhael J, Manola J, Dueck AC, Hayman S, Oettel K, Kanate AS, Lonial S, Rajkumar SV. Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study. Blood Cancer J. 2018 Aug 29;8(9):86. doi: 10.1038/s41408-018-0110-7.
PubMed 30190454
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT00790842
- Acronym / sponsor ID
- PrE1003 / PrE1003
- Conditions
- Multiple Myeloma, Plasma Cell Neoplasm
- Keywords
- Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Multiple Myeloma with Renal Dysfunction, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 63 participants (actual)
- Lead sponsor
- PrECOG, LLC.University, hospital or other
- Collaborators
- Celgene
- Study start
- 21 Jan 2009 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 24 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.
Detailed description
Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed. Several novel agents for MM have now become available including the immunomodulatory drugs thalidomide, lenalidomide, as well as the proteasome inhibitor, bortezomib. Each of these agents is undergoing extensive clinical evaluation in combination with other therapies to produce unprecedented response rates in newly diagnosed and relapsed MM. Lenalidomide has proven to be a highly effective treatment agent, particularly when used in combination with dexamethasone but is renally excreted and little information is available about its use in myeloma patients with impaired kidney function (20% have renal failure at some time after diagnosis). Defining a safe and effective dose of lenalidomide to use is a critical step in MM treatment.
OUTLINE: This is a Phase I, dose-escalation study of lenalidomide followed by a Phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-60 mL/min] vs severe [creatinine clearance <30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance <30 mL/min and requires dialysis]).
Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone 40 mg on days 1, 8, 15, and 22. There is a 7 day rest (days 22-28) from lenalidomide. Each cycle is 28 days and repeated in the absence of disease progression or unacceptable toxicity.
Patients enrolled in the phase II portion of the study will undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide (Mayo Clinic sites only).
After completion of study treatment, patients are followed every 6 months for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - CrCl 30-60 mL/min | Experimental | Drug: Lenalidomide, Drug: Dexamethasone, Drug: AnticoagulantsCreatinine clearance 30 - 60 mL/min, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. |
| Group B, CrCl < 30 mL/min | Experimental | Drug: Lenalidomide, Drug: Dexamethasone, Drug: AnticoagulantsCreatinine clearance < 30 mL/min, not on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. |
| Group C, CrCl < 30 mL/min, on dialysis | Experimental | Drug: Lenalidomide, Drug: Dexamethasone, Drug: AnticoagulantsCreatinine clearance < 30 mL/min and on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Diagnosed with previously treated multiple myeloma.
- Measurable disease assessed by one of the following ≤21 days prior to registration:
- All previous cancer therapy including chemotherapy, radiation, hormonal therapy and surgery, must be discontinued ≥2 weeks prior to registration.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (16 listed)
- Concurrent use of other anti-cancer agents or treatments. Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.
- Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- HIV-positive patients on combination antiretroviral therapy.
- Known hypersensitivity to thalidomide or other immunomodulatory drugs.
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 |
|---|---|---|
| LenalidomideAlso: RevlimidGiven by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity. | Drug | Group A - CrCl 30-60 mL/min, Group B, CrCl < 30 mL/min, Group C, CrCl < 30 mL/min, on dialysis |
| DexamethasoneAlso: Decadron40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity. | Drug | Group A - CrCl 30-60 mL/min, Group B, CrCl < 30 mL/min, Group C, CrCl < 30 mL/min, on dialysis |
| AnticoagulantsAlso: Aspirin, Heparin, Low Molecular Weight Heparin, CoumadinAnticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. | Drug | Group A - CrCl 30-60 mL/min, Group B, CrCl < 30 mL/min, Group C, CrCl < 30 mL/min, on dialysis |
Primary outcome
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
Time frame: First cycle of therapy (28 days)
Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: * Grade 3 or higher neutropenia with fever ≥38.5 degrees C * Grade 4 neutropenia ≥7 days * Grade 4 or higher thrombocytopenia * Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
Time frame: 56 months
Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components
6 secondary outcomes
Overall Survival Time
Time frame: 56 months
Duration of Response
Time frame: 56 months
Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
Time frame: 56 months
Renal Function Over Time
Time frame: 56 months
Pharmacokinetics of Lenalidomide in Impaired Renal Function
Time frame: 56 months
Progression-free Survival
Time frame: 56 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30190454Mikhael J, Manola J, Dueck AC, Hayman S, Oettel K, Kanate AS, Lonial S, Rajkumar SV. Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study. Blood Cancer J. 2018 Aug 29;8(9):86. doi: 10.1038/s41408-018-0110-7.
- Individual participant dataSharing planned: No. Data is proprietary.
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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.
Joseph R. Mikhael, MD study chair
Mayo Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide, Dexamethasone and Anticoagulants in people with Multiple Myeloma and Plasma Cell Neoplasm, run by PrECOG, LLC. at 16 sites 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 21 inclusion and 16 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 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 Oct 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?
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy (time frame: First cycle of therapy (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790842, which also lists 1 linked publication.
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 24 Oct 2018.