Multiple MyelomaNCT03375567
Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma With Carfilzomib Lenalidomide Dexamethasone
A study testing Guided Lesion Biopsies and Standard Lesion Biopsies in people with Multiple Myeloma, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to compare the detection rate of residual/refractory disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after induction therapy with carfilzomib, lenalidomide and dexamethasone regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Guided Lesion Biopsies and Standard Lesion Biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be diagnosed with symptomatic multiple myeloma within 90 days prior to registration
- Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 35 days prior to randomization:
- Detectable monoclonal protein (M-protein) on serum protein electrophoresis
- Detectable monoclonal protein on a 24 hour urine protein electrophoresis
- Abnormal serum kappa to lambda free light chain ratio (< 0.26 or > 1.65)
- Clonal bone marrow plasma cells ≥10%
Show all 29Show fewer
- Myeloma-defining bone lesion or extramedullary plasmacytoma on advanced imaging
- The following laboratory values must be obtained within 35 days prior to registration:
- Hemoglobin ≥ 7 g/dL
- Platelet count ≥ 50,000 cells/mm3
- Absolute neutrophil count ≥ 500 cells/mm3
- Calculated creatinine clearance ≥ 15 mL/min
- Bilirubin ≤ 2 mg/dL
- SGPT (ALT) and SGOT (AST) < 3 times the upper limit of normal. (Red blood cell and platelets transfusion is allowed to maintain the above goal) Patients may have received one cycle (28 days or less) of prior chemotherapy and no more than 320mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. They may have received lenalidomide, bortezomib, or cyclophosphamide for treatment of symptomatic myeloma. They may not have received prior carfilzomib.
- Prior radiation therapy to symptomatic lesions is allowed provided 10 days is allowed between the completion of radiation therapy and start of protocol treatment.
- Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted. Prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permitted.
- Patients must not have active, uncontrolled seizure disorder. Patients must have had no seizures in the last 6 months.
- Patients must not have uncontrolled concurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study.
- ECOG performance status 0, 1, or 2. (PS 3 allowed if secondary to pain)
- Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible.
- Patients must not have Grade 3 or higher peripheral neuropathy by CTCAE 4.0.
- Patients must not have active, uncontrolled infection requiring intravenous antibiotic therapy.
- Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to receive anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
- Patients must not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months and must have left ventricular ejection fraction of at least 40%.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy (currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast are not excluded).
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 14 days prior starting lenalidomide 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, 14 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 patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- The patient must be able to undergo advanced imaging with either WB-MRI or PET scan.
- The patient must not have any inherited or acquired bleeding diathesis increasing the risk of hemorrhage with guided biopsies.
- HIV infection is not excluded. Known HIV positive patients must have documented CD4 cell count ≥ 350/mm3 and no history of AIDS-related illness.
Who cannot join
- Violation of inclusion criteria specifics
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Cancer Center
New Haven, Connecticut, 06520-8028
About this study
Official title: Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma With Carfilzomib Lenalidomide Dexamethasone (CRD)
The primary objective of this study is to compare the detection rate of residual/refractory disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after induction therapy with carfilzomib, lenalidomide and dexamethasone regimen.
Read the detailed description
Carfilzomib, lenalidomide and dexamethasone (CRD) combination therapy is generally associated with high response rates. The expectation is that induction therapy with CRD will result in responses within the myeloma lesions. Extrapolating from the published experience on standard bone marrow response rates with CRD regimen, it is predicted that guided biopsy of myeloma lesions will reveal VGPR/CR/nearCR rate up to 50%. Further, it can be hypothesized that myeloma lesion biopsy will increase the detection rate of residual/refractory disease by about 20%, as compared with standard bone marrow evaluation. Thus, it is expected that myeloma lesion biopsy response rate may be discordant from the standard bone marrow response rate. The identification of patients with large residual disease burden in the myeloma lesions will indicate the need for further salvage therapy. Based on this, it is expected that advanced imaging with guided myeloma lesion biopsy will result in significantly improved response assessment strategy after induction therapy, and will allow better selection of patients prior to autologous stem cell transplant.
- Conditions
- Multiple Myeloma
- Being tested
- Guided Lesion Biopsies, Standard Lesion Biopsies
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Lesion BiopsiesProcedure or surgery
After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.
Standard Lesion BiopsiesProcedure or surgery
After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.
| Study group | Role | What they receive |
|---|---|---|
| Guided Lesion Biopsies | Experimental | After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique. Receives: Procedure: Guided Lesion Biopsies |
| Standard Lesion Biopsies | Active comparator | After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique. Receives: Procedure: Standard Lesion Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of residual/refractory
The purpose of this outcome is to compare standard biopsy procedures with the image guided approach. International Myeloma Working Group (IMWG) Criteria for Response and Progression standards will be used to determine the detection rate of residual/refractory.
Measured: 4 months
Secondary outcomes (2)
Myeloma lesion response rate
International Myeloma Working Group (IMWG) Criteria for Response and Progression standards will be used.
Measured: 4 months
Overall clinical response rate
International Myeloma Working Group (IMWG) Criteria for Response and Progression standards will be used.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start4 Jun 2018
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Neparidze, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375567
- Sponsor's protocol ID
- 2000021421
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2017
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Response Assessment by Advanced Imaging and Myeloma Lesion Biopsies During Induction Therapy of Multiple Myeloma With Carfilzomib Lenalidomide Dexamethasone (CRD)
- ClinicalTrials.gov ID
- NCT03375567
- Acronym / sponsor ID
- 2000021421
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the detection rate of residual/refractory disease based on standard bone marrow biopsy versus guided myeloma lesion biopsy after induction therapy with carfilzomib, lenalidomide and dexamethasone regimen.
Detailed description
Carfilzomib, lenalidomide and dexamethasone (CRD) combination therapy is generally associated with high response rates. The expectation is that induction therapy with CRD will result in responses within the myeloma lesions. Extrapolating from the published experience on standard bone marrow response rates with CRD regimen, it is predicted that guided biopsy of myeloma lesions will reveal VGPR/CR/nearCR rate up to 50%. Further, it can be hypothesized that myeloma lesion biopsy will increase the detection rate of residual/refractory disease by about 20%, as compared with standard bone marrow evaluation. Thus, it is expected that myeloma lesion biopsy response rate may be discordant from the standard bone marrow response rate. The identification of patients with large residual disease burden in the myeloma lesions will indicate the need for further salvage therapy. Based on this, it is expected that advanced imaging with guided myeloma lesion biopsy will result in significantly improved response assessment strategy after induction therapy, and will allow better selection of patients prior to autologous stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.
| Arm | Type | Receives |
|---|---|---|
| Guided Lesion Biopsies | Experimental | Procedure: Guided Lesion BiopsiesAfter patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique. |
| Standard Lesion Biopsies | Active comparator | Procedure: Standard Lesion BiopsiesAfter patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patients must be diagnosed with symptomatic multiple myeloma within 90 days prior to registration
- Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 35 days prior to randomization:
- Detectable monoclonal protein (M-protein) on serum protein electrophoresis
- Detectable monoclonal protein on a 24 hour urine protein electrophoresis
- Abnormal serum kappa to lambda free light chain ratio (< 0.26 or > 1.65)
Key exclusion criteria (1 listed)
- Violation of inclusion criteria specifics
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 |
|---|---|---|
| Guided Lesion BiopsiesAfter patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique. | Procedure or surgery | Guided Lesion Biopsies |
| Standard Lesion BiopsiesAfter patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique. | Procedure or surgery | Standard Lesion Biopsies |
Primary outcome
Detection rate of residual/refractory
Time frame: 4 months
The purpose of this outcome is to compare standard biopsy procedures with the image guided approach. International Myeloma Working Group (IMWG) Criteria for Response and Progression standards will be used to determine the detection rate of residual/refractory.
2 secondary outcomes
Myeloma lesion response rate
Time frame: 4 months
Overall clinical response rate
Time frame: 4 months
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 24 Feb 2022.
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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.
Natalia Neparidze, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Lesion Biopsies and Standard Lesion Biopsies in people with Multiple Myeloma, run by Yale University 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 29 inclusion and 1 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 24 Feb 2022. 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.
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?
Detection rate of residual/refractory (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.