Multiple MyelomaPhase 2RVD LiteNCT01782963
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
A Phase 2 study testing Lenalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Massachusetts General Hospital at 6 sites in United States.
Trial summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2013to Dec 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented symptomatic myeloma, with organ damage related to myeloma
- Myeloma that is measurable either by serum or urine evaluation of the monoclonal component or by assay of serum free light chains
- Must commit to complete abstinence from heterosexual contact or begin two acceptable method of birth control, one highly effective method and one additional effective (barrier) method
Who cannot join
- Eligible for autologous stem cell transplantation
- HIV positive on combination antiretroviral therapy
- Pregnant or breastfeeding
- Treated with any prior systemic therapy
- Primary amyloidosis or myeloma complicated by amyloidosis
- Receiving other investigational agents within 14 days of the start of this trial or during this trial
Show all 12Show fewer
- Known brain metastases
- Poor tolerability or known allergy to any of the study drugs or similar compounds
- Intercurrent illness
- Previous history of another malignant condition except for basal cell carcinoma or stage I cervical cancer
- Inability to comply with an anti-thrombotic treatment regimen
- Peripheral neuropathy greater than or equal to grade 2
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
John Hopkins University
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital/North Shore Cancer Center
Danvers, Massachusetts, 01923
About this study
Official title: A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.
Read the detailed description
If you are willing to participate in this study you will be asked to undergo some screening procedures and tests to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care. They may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, physical exam, performance status, vital signs, neurological exam, bone imaging studies, chest x-ray, bone marrow aspirate, ECG, blood tests and urine tests. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.
For cycles 1-9 (each cycle lasts 35 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib- once a day on Days 1, 8, 15 and 22. If you are one of the first ten patients enrolled you will get Bortezomib as an intravenous injection for the first cycle. You will get Bortezomib as an injection under the skin for all other cycles. If you are not one of the first 10 patients enrolled you will get Bortezomib as an injection under the skin for all cycles. Dexamethasone-if you are 75 years old or younger you will get Dexamethasone on Days 1, 2, 8, 9, 15, 16, 22 and 23. If you are more than 75 years old you will get Dexamethasone on Days 1, 8, 15 and 22. You will take Dexamethasone by mouth at the same time each day.
For cycles 10-15 (each cycle lasts 28 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib-Once a day on Days 1 and 15. You will get Bortezomib as an injection under the skin. You will be given a drug diary to record taking your doses of the drugs. The study staff will tell you how to complete the diary.
During the study you will have to come to the clinic for visits. The tests and procedures that will be done at each visit are listed below:
Day 1 of all cycles: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum (cycle 1 only), urine test.
Day 8 of cycles 1-9: questions about health, medications etc., vital signs, blood tests.
Day 15 of all cycles: questions about health, medications, etc., vital signs, blood tests, pregnancy test.
Day 22 of cycles 1-9: questions about health, medications, etc., vital signs, blood tests.
After the final dose of the study drug you will have an End of Treatment visit. The following tests and procedures will be done at this visit: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum, urine test.
After your End of Treatment visit, we would like to follow your status every 2 months until your disease gets worse. The following tests and procedures will be done at these follow-up visits: questions about health, medications, symptoms etc., blood tests and urine test.
If you are one of the first twenty patients enrolled in the study you will also be asked to provide additional blood samples to study what the body does to the study drug. We will take one sample at five time points during cycle 1 and 2. Collection of these samples may require you to come back into the clinic on additional days when you are not receiving study drugs.
You will be in this research study for about 15 months. You can be in this study for a maximum of 15 cycles. If your disease gets worse before the 15th cycle you will be taken off the study.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Bortezomib, Dexamethasone
- Keywords
- Newly diagnosed
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
BortezomibDrug
Also called Velcade
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)
Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Receives: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following:
- Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM)
- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM
- VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours
- PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
Measured: 2 years
Secondary outcomes (7)
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
A summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).
Measured: 2 years
Median Progression Free Survival
The median amount of time as measured from the start of treatment until either death or progression.
Progressive disease requires 1 or more of the following:
- >=25% increase from lowest response level in serum M-protein (>=0.5 g/dL absolute increase) and/or urine M-component (>=200 mg/24hr absolute increase)
- >=25% increase in the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL). Only for use in patients without measurable serum and M-protein levels.
- >=25% increase in bone marrow plasma cell percentage (absolute percentage >=10%)
- New or increase in existing bone lesions or soft tissue plasmacytomas
- Hypercalcemia (serum calcium >11.5 mg/dL) due solely to the plasma cell proliferative disorder.
Measured: From the start of treatment until death or progression or until 3 years after the last participant is enrolled
Median Overall Survival
The median overall survival as measured from the start of treatment until the time of death due to any cause.
Measured: From the start of treatment until death or until 5 years after the time of disease progression
Median Time to Response
Median amount of time from the start of treatment until first documented response as defined by the International Myeloma Working Group uniform response criteria
Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
Measured: From the start of treatment until the time of first documented response, median duration of 1.1 months
Response Rate With Respect to Cytogenetic Characteristics
Response rate was assessed using the International Myeloma Working Group uniform response criteria. Stringent complete response, Complete Response, Very Good Partial Response, and Partial Response are defined in outcome measure 1.
- MR included participants in whom some, but not all, criteria for PR were fulfilled, providing the remaining criteria satisfied the requirements for MR. Required all of the following:
- ≥25% to ≤ 49% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.
- If present, a 50 to 89% reduction in 24-hour light chain excretion, which still exceeds 200 mg/24 h, for at least two determinations six weeks apart.
- 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for at least six weeks.
- No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).
- Stable Disease: Not meeting the criteria for minimal response or
Measured: 2 years
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.
Measured: Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose
Pharmacogenomic Markers of Neuropathy
To evaluate pharmacogenomic markers among patients with treatment related polyneuropathy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2017
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.
- More trials run by Massachusetts General HospitalThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noopur Raje, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782963
- Sponsor's protocol ID
- 12-498
- Acronym
- RVD Lite
- Status last verified
- Oct 2018
- First submitted
- 15 Jan 2013
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gustine JN, O'Donnell EK, Laubach JP, Yee AJ, Huff CA, Ghobrial IM, Burke JN, Harrington CC, Munshi NC, Anderson KC, Richardson PG, Raje NS. Long-term outcomes of modified-intensity lenalidomide, bortezomib and dexamethasone (RVD-lite) in transplant-ineligible multiple myeloma: final report of a phase II trial. Clin Cancer Res. 2026 Oct 5. doi: 10.1158/1078-0432.CCR-26-0794. Online ahead of print.
PubMed 42832368
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01782963
- Acronym / sponsor ID
- RVD Lite / 12-498
- Conditions
- Multiple Myeloma
- Keywords
- Newly diagnosed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.
Detailed description
If you are willing to participate in this study you will be asked to undergo some screening procedures and tests to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care. They may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, physical exam, performance status, vital signs, neurological exam, bone imaging studies, chest x-ray, bone marrow aspirate, ECG, blood tests and urine tests. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.
For cycles 1-9 (each cycle lasts 35 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib- once a day on Days 1, 8, 15 and 22. If you are one of the first ten patients enrolled you will get Bortezomib as an intravenous injection for the first cycle. You will get Bortezomib as an injection under the skin for all other cycles. If you are not one of the first 10 patients enrolled you will get Bortezomib as an injection under the skin for all cycles. Dexamethasone-if you are 75 years old or younger you will get Dexamethasone on Days 1, 2, 8, 9, 15, 16, 22 and 23. If you are more than 75 years old you will get Dexamethasone on Days 1, 8, 15 and 22. You will take Dexamethasone by mouth at the same time each day.
For cycles 10-15 (each cycle lasts 28 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib-Once a day on Days 1 and 15. You will get Bortezomib as an injection under the skin. You will be given a drug diary to record taking your doses of the drugs. The study staff will tell you how to complete the diary.
During the study you will have to come to the clinic for visits. The tests and procedures that will be done at each visit are listed below:
Day 1 of all cycles: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum (cycle 1 only), urine test.
Day 8 of cycles 1-9: questions about health, medications etc., vital signs, blood tests.
Day 15 of all cycles: questions about health, medications, etc., vital signs, blood tests, pregnancy test.
Day 22 of cycles 1-9: questions about health, medications, etc., vital signs, blood tests.
After the final dose of the study drug you will have an End of Treatment visit. The following tests and procedures will be done at this visit: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum, urine test.
After your End of Treatment visit, we would like to follow your status every 2 months until your disease gets worse. The following tests and procedures will be done at these follow-up visits: questions about health, medications, symptoms etc., blood tests and urine test.
If you are one of the first twenty patients enrolled in the study you will also be asked to provide additional blood samples to study what the body does to the study drug. We will take one sample at five time points during cycle 1 and 2. Collection of these samples may require you to come back into the clinic on additional days when you are not receiving study drugs.
You will be in this research study for about 15 months. You can be in this study for a maximum of 15 cycles. If your disease gets worse before the 15th cycle you will be taken off the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Lenalidomide, Drug: Bortezomib, Drug: DexamethasoneInduction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented symptomatic myeloma, with organ damage related to myeloma
- Myeloma that is measurable either by serum or urine evaluation of the monoclonal component or by assay of serum free light chains
- Must commit to complete abstinence from heterosexual contact or begin two acceptable method of birth control, one highly effective method and one additional effective (barrier) method
Key exclusion criteria (12 listed)
- Eligible for autologous stem cell transplantation
- HIV positive on combination antiretroviral therapy
- Pregnant or breastfeeding
- Treated with any prior systemic therapy
- Primary amyloidosis or myeloma complicated by amyloidosis
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: Revlimid | Drug | Treatment Arm |
| BortezomibAlso: Velcade | Drug | Treatment Arm |
| Dexamethasone | Drug | Treatment Arm |
Primary outcome
Objective Response Rate
Time frame: 2 years
Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following: * Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) * CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours * PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required
7 secondary outcomes
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Time frame: 2 years
Median Progression Free Survival
Time frame: From the start of treatment until death or progression or until 3 years after the last participant is enrolled
Median Overall Survival
Time frame: From the start of treatment until death or until 5 years after the time of disease progression
Median Time to Response
Time frame: From the start of treatment until the time of first documented response, median duration of 1.1 months
Response Rate With Respect to Cytogenetic Characteristics
Time frame: 2 years
Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection
Time frame: Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose
Pharmacogenomic Markers of Neuropathy
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42832368Gustine JN, O'Donnell EK, Laubach JP, Yee AJ, Huff CA, Ghobrial IM, Burke JN, Harrington CC, Munshi NC, Anderson KC, Richardson PG, Raje NS. Long-term outcomes of modified-intensity lenalidomide, bortezomib and dexamethasone (RVD-lite) in transplant-ineligible multiple myeloma: final report of a phase II trial. Clin Cancer Res. 2026 Oct 5. doi: 10.1158/1078-0432.CCR-26-0794. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Massachusetts General Hospital at 6 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 3 inclusion and 12 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 31 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 6 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 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 13 Mar 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?
Objective Response Rate (time frame: 2 years). 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 NCT01782963, 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 31 Oct 2018.