Multiple MyelomaPhase 2DexTRNCT00538824
Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing dexamethasone, thalidomide and lenalidomide in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Study Objectives 1. To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as… 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?
- dexamethasone, thalidomide and lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 22 Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must voluntarily sign and understand written informed consent.
- Age > 18 years at the time of signing the consent form.
- Histologically confirmed Salmon-Durie stage II or III MM. Stage I MM patients will be eligible if they display poor prognostic factors (ß2M ≥5.5 mg/L, plasma cell proliferation index ≥5%, albumin of less then 3.0, and unfavorable cytogenetics).
- Relapsed or refractory myeloma as defined by Appendix II, table 1, progression of disease either after prior therapy or lack of response to currently used therapy.
- Prior treatment with prior lenalidomide and thalidomide as single agents or in combination with dexamethasone, but not in combination with each other.
- No anti-myeloma therapy within 14 days prior to initiation of study treatment. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
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- Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma.
- All study participants must be registered into the mandatory RevAssist® and S.T.E.P.S.® programs, and be willing and able to comply with the requirements of the RevAssist® and S.T.E.P.S.® programs.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and thalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks 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 females of child bearing potential even if they have had a successful vasectomy.
- Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- Life expectancy ≥ 3 months
- Subjects must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥1000 cells/mm3 (1.0 x 109/L)
- Platelets count ≥ 75,000/mm3 (75 x 109/L)
- Serum SGOT/AST <3.0 x upper limits of normal (ULN)
- Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
- Serum creatinine <2.5 mg/dL (221 µmol/L)
- Serum total bilirubin <2.0 mg/dL (34 µmol/L)
Who cannot join
- Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years.
- Myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Pregnant or lactating females are ineligible.
- Given the potential of the study drugs to trigger or worsen HIV viremia and the incidence of opportunistic infections inpatients infected with the HIV virus, HIV-1 or HIV-2 positive patients will be excluded. The interactions of HAART with study drugs have not been determined.
- Active hepatitis B or hepatitis C infection.
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- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
- Known hypersensitivity to dexamethasone, lenalidomide, or thalidomide.
- History of thromboembolic event within the past 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: A Phase II Study of Dexamethasone (DECADRON®), Thalidomide (THALOMID®), and Lenalidomide (REVLIMID®) for Subjects With Relapsed or Refractory Multiple Myeloma
Study Objectives
- To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as monotherapies.
- To evaluate the safety of the combination of lenalidomide, dexamethasone, and thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.
Read the detailed description
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with both thalidomide and lenalidomide in separate regimens each used as a single agent or in combination with corticosteroids. Up to 45 patients will be enrolled. Patients who sign informed consent form and RevAssist® and S.T.E.P.S® patient agreement form and fulfill all eligibility criteria will be enrolled.
DexTR therapy:
Cycles 1-4
- Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
- Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.
- Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
- Prophylactic medications, such as medications for thrombosis risk, will be given.
After completing 4 cycles:
- Patients who demonstrate disease progression at any time will be taken off study.
- Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
- Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
Maintenance therapy:
Maintenance therapy will consist of:
- Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)
- Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of < 40cc/min*
- Patients who finished induction therapy with DexTR at a reduced dose of lenalidomide will start maintenance therapy at the same dose of lenalidomide on which they ended induction therapy. For patients with a creatinine clearance of < 40cc / minute, the lenalidomide dose will be the lower of their last induction therapy dose or 15mg daily on days 1 - 21 out of a 28 day cycle.
Serial clinic visits and laboratory measurements will be performed to monitor for treatment response. Those patients who demonstrate progression of disease at any point during DexTR therapy will be taken off study.
At the end of every cycle (which may coincide with day 1 of the new cycle), response and toxicity will be evaluated. During cycle 1, patients will have lab work done weekly (CBC with differential and blood electrolytes). All patients will remain on study until disease progression or side effects become excessive. Patients who achieve a stable plateau and are on maintenance therapy as defined above may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation.
- Conditions
- Multiple Myeloma
- Being tested
- dexamethasone, thalidomide, lenalidomide
- Keywords
- myeloma, relapsed or refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
After completing 4 cycles:
- Patients who demonstrate disease progression at any time will be taken off study.
- Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
- Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
Maintenance therapy will consist of:
- Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)
thalidomideDrug
Cycles 1-4
- Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.
After completing 4 cycles:
- Patients who demonstrate disease progression at any time will be taken off study.
- Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
- Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
lenalidomideDrug
Cycles 1-4 • Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
After completing 4 cycles:
- Patients who demonstrate disease progression at any time will be taken off study.
- Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
- Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
Maintenance therapy will consist of:
- Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of < 40cc/min*
| Study group | Role | What they receive |
|---|---|---|
| DexTR (all patients) | Experimental | All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. Receives: Drug: dexamethasone; Drug: thalidomide; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Drug Combination on Multiple Myeloma
The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
Measured: The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startDec 2007
- Primary completion22 Sep 2010
- Study completion22 Sep 2010
Why it stopped: low 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.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Ruben Niesvizky, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538824
- Sponsor's protocol ID
- 0708009381
- Other IDs
- RV-MM-PI-0132
- Acronym
- DexTR
- Status last verified
- May 2018
- First submitted
- 2 Oct 2007
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Dexamethasone (DECADRON®), Thalidomide (THALOMID®), and Lenalidomide (REVLIMID®) for Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00538824
- Acronym / sponsor ID
- DexTR / 0708009381
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, relapsed or refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Dec 2007 (actual)
- Primary completion
- 22 Sep 2010 (actual)
- Study completion
- 22 Sep 2010 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Posted 8 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objectives
- To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as monotherapies.
- To evaluate the safety of the combination of lenalidomide, dexamethasone, and thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.
Detailed description
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with both thalidomide and lenalidomide in separate regimens each used as a single agent or in combination with corticosteroids. Up to 45 patients will be enrolled. Patients who sign informed consent form and RevAssist® and S.T.E.P.S® patient agreement form and fulfill all eligibility criteria will be enrolled.
DexTR therapy:
Cycles 1-4
- Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.
- Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle.
- Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle.
- Prophylactic medications, such as medications for thrombosis risk, will be given.
After completing 4 cycles:
- Patients who demonstrate disease progression at any time will be taken off study.
- Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.
- Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.
Maintenance therapy:
Maintenance therapy will consist of:
- Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)
- Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of < 40cc/min*
- Patients who finished induction therapy with DexTR at a reduced dose of lenalidomide will start maintenance therapy at the same dose of lenalidomide on which they ended induction therapy. For patients with a creatinine clearance of < 40cc / minute, the lenalidomide dose will be the lower of their last induction therapy dose or 15mg daily on days 1 - 21 out of a 28 day cycle.
Serial clinic visits and laboratory measurements will be performed to monitor for treatment response. Those patients who demonstrate progression of disease at any point during DexTR therapy will be taken off study.
At the end of every cycle (which may coincide with day 1 of the new cycle), response and toxicity will be evaluated. During cycle 1, patients will have lab work done weekly (CBC with differential and blood electrolytes). All patients will remain on study until disease progression or side effects become excessive. Patients who achieve a stable plateau and are on maintenance therapy as defined above may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DexTR (all patients) | Experimental | Drug: dexamethasone, Drug: thalidomide, Drug: lenalidomideAll patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject must voluntarily sign and understand written informed consent.
- Age > 18 years at the time of signing the consent form.
- Histologically confirmed Salmon-Durie stage II or III MM. Stage I MM patients will be eligible if they display poor prognostic factors (ß2M ≥5.5 mg/L, plasma cell proliferation index ≥5%, albumin of less then 3.0, and unfavorable cytogenetics).
- Relapsed or refractory myeloma as defined by Appendix II, table 1, progression of disease either after prior therapy or lack of response to currently used therapy.
- Prior treatment with prior lenalidomide and thalidomide as single agents or in combination with dexamethasone, but not in combination with each other.
Key exclusion criteria (10 listed)
- Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years.
- Myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Pregnant or lactating females are ineligible.
- Given the potential of the study drugs to trigger or worsen HIV viremia and the incidence of opportunistic infections inpatients infected with the HIV virus, HIV-1 or HIV-2 positive patients will be excluded. The interactions of HAART with study drugs have not been determined.
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 |
|---|---|---|
| dexamethasoneCycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy. Maintenance therapy will consist of: • Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle) | Drug | DexTR (all patients) |
| thalidomideCycles 1-4 • Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy. | Drug | DexTR (all patients) |
| lenalidomideCycles 1-4 • Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy. Maintenance therapy will consist of: • Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of < 40cc/min* | Drug | DexTR (all patients) |
Primary outcome
Effect of Drug Combination on Multiple Myeloma
Time frame: The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks
The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Niesvizky, MD principal investigator
Weill Medical College of Cornell University
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, thalidomide and lenalidomide in people with Multiple Myeloma, run by Weill Medical College of Cornell 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 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2017). 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?
Effect of Drug Combination on Multiple Myeloma (time frame: The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks). 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 6 Jun 2018.