Multiple MyelomaPhase 2BRdNCT01701076
Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Bendamustine in people with Multiple Myeloma, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Almost all patients with multiple myeloma who survive initial treatment will eventually relapse and require further therapy. Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months for… 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?
- Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Feb 2016
- Phase
- Phase 2
- 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
- Written informed consent
- Patients with first relapsed or refractory multiple myeloma (including patients with relapse after high dose chemotherapy followed by autologous stem cell transplantation) who have received no more than one prior line of anti-myeloma treatment
- Treatment with a lenalidomide/ dexamethasone-based 2nd-line regimen is indicated and intended
- Measurable disease as defined by at least one of the following 3 measurements
- serum monoclonal protein level ≥ 1 g/dl (≥ 10 g/l) or
- urine M-protein level ≥ 200 mg/24hours or
Show all 29Show fewer
- serum FLC assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) provided serum FLC ratio is abnormal
- ECOG performance status 0, 1, or 2
- Age ≥ 18 years
- All previous cancer therapy (except corticosteroid therapy), including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
- No prior treatment with a bendamustine-containing regimen allowed
- Prior treatment with lenalidomide is allowed if the treatment is completed > 12 month prior to study entry and the patient responded to prior lenalidomide treatment
- Adequate hematological values:
- absolute neutrophil count ≥ 1.5 x 109/L
- platelets ≥ 100 x 109/L
- hemoglobin > 80 g/L, unless considered to be caused by the underlying hematologic malignancy, based on the investigator's clinical judgement
- Adequate hepatic function:
- total bilirubin < 1.2 mg/dL
- AST (SGOT) ≤ 2.5 x ULN
- Adequate renal function:
- o calculated creatinine clearance > 50 ml/min, according to the formula of Cockcroft-Gault
- Disease free of prior malignancies for > 5 years unless the patient
- has been treated with a curative intent and is considered to be in complete remission for ≥2 years prior to study enrolment
- or has a curatively-treated
- basal cell/ squamous cell carcinoma of the skin,
- carcinoma "in situ"of the cervix,
- ductal breast carcinoma in situ with complete surgical resection (i.e. negative margins),
- medullary or papillary thyroid tumor
- or low grade, early stage localized prostate cancer treated surgically with curative intent
Who cannot join
- Pregnant or breast feeding females
- Any prior use of bendamustine
- Patients who are unable or unwillingly to undergo antithrombotic therapy
- Any serious underlying medical condition (at the judgment of the investigator) which impairs the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorder)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she would participate in the study or any condition significantly confounding the ability to interpret data from the study, based on the local investigator's judgement
- Severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3)
Show all 14Show fewer
- Use of any other experimental drug or therapy/ treatment in a clinical trial within 30 days prior to trial entry
- Known hypersensitivity to study drug(s) or hypersensitivity to any other component of the study drugs
- Any concurrent antineoplastic therapy with chemotherapeutic agents or biologic agents or radiation therapy
- Any major surgical procedure within 30 days prior to study therapy
- Known chronic hepatitis B or C, known HIV infection
- Jaundice or any other severe damage of the liver parenchyma
- Any contraindication for the treatment with bendamustine, lenalidomide, dexamethasone and / or pegfilgrastim in accordance with the appropriate SmPCs
- Any other concomitant drugs contraindicated for use with the study drugs according to the national health authorities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma
Almost all patients with multiple myeloma who survive initial treatment will eventually relapse and require further therapy.
Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone until disease progression is therefore considered a standard therapy for second line treatment in multiple myeloma patients. However, only a relatively low rate of high quality response (CR, complete response and VGPR, very good partial response) is achieved. High quality responses are associated with with improved progression-free survival and overall survival [4].
Read more
Trial: The aim of this trial is to improve high quality response rates for patients with relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved by the addition a third anti-myeloma drug (bendamustine) to the established backbone of lenalidomide/ dexamethasone.
Treatment regimen:
- Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75years) d 1, 8, 15, 22.
- Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75 years) d 1, 8, 15, 22.
Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe neutropenia.
The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this aim is achieved, the treatment of bendamustine in combination with the established lenalidomide/ dexamethasone regimen will be considered promising.
Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.
Read the detailed description
Assessments for efficacy / response evaluation:
- M-protein quantitation in serum and 24 h urine collection samples by serum- and urine protein electrophoresis
- Quantitation of immunoglobulin levels by nephelometry
- Serum and urine immunofixation
- Free light chain concentrations and ratio in the serum
- Plasma cell percentage in the bone marrow by conventional cytology and biopsy with immunohistochemistry
- Radiologic assessments of the skeleton
Response criteria: Response will be assessed according to IMWG criteria
- Conditions
- Multiple Myeloma
- Being tested
- Bendamustine
- Keywords
- Relapsed / refractory multiple myeloma, 2nd line treatment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Lenalidomide, Dexamethasone, Pegfilgrastim
Induction treatment phase (cycle 1-6):
- Bendamustine 75 mg/m2 i.v day 1 and 2
- Lenalidomide 25 mg p.o. day 1-21
- Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22
- Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia
Maintenance treatment phase (cycles 7-18):
- Lenalidomide 25 mg p.o. day 1-21
- Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine | Experimental | All patients are treated with bendamustine in combination with lenalidomide and dexamethasone for a maximum of 6 cycles. Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (combined CR-/VGPR-rate) achieved during the induction treatment phase or within four weeks after the last administration of six induction cycles of the BRd regimen
Measured: Every 4 weeks up to 7 months
Secondary outcomes (5)
Objective response rates (sCR, CR, VGPR, PR, MR)
Measured: Every 4 weeks up to 7 months
Best response (sCR, CR, VGPR, PR, MR)
Measured: Every 4 weeks up to 36 months
Time to progression (TTP)
Measured: Every 4 weeks up to 36 months
Overall survival (OS)
Measured: Every 8 weeks up to 36 months
Safety and tolerability
- Type, frequency, severity, and relationship of adverse events to study therapy
- According to NCI CTCAE v4.0
Measured: Every 4 weeks until 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Mundipharma Research GmbH & Co KG, Mundipharma Medical Company, Amgen
- Responsible party
- Principal investigator, PD Dr. Ulrich Mey, Kantonsspital Graubünden
- Investigators
- Ulrich Mey, MD, Study chair, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701076
- Sponsor's protocol ID
- CTU10.041/BRd
- Other IDs
- 2010-022253-42
- Acronym
- BRd
- Status last verified
- Aug 2016
- First submitted
- 27 Sep 2012
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
PubMed 18032763Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
PubMed 18032762Dimopoulos MA, Chen C, Spencer A, Niesvizky R, Attal M, Stadtmauer EA, Petrucci MT, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Leukemia. 2009 Nov;23(11):2147-52. doi: 10.1038/leu.2009.147. Epub 2009 Jul 23.
PubMed 19626046Harousseau JL, Attal M, Avet-Loiseau H. The role of complete response in multiple myeloma. Blood. 2009 Oct 8;114(15):3139-46. doi: 10.1182/blood-2009-03-201053. Epub 2009 Jul 28.
PubMed 19638622Lentzsch S, O'Sullivan A, Kennedy RC, Abbas M, Dai L, Pregja SL, Burt S, Boyiadzis M, Roodman GD, Mapara MY, Agha M, Waas J, Shuai Y, Normolle D, Zonder JA. Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study. Blood. 2012 May 17;119(20):4608-13. doi: 10.1182/blood-2011-12-395715. Epub 2012 Mar 26.
PubMed 22451423Pönisch W, Heyn S, Wagner I, et al. Combined Bendamustine, Prednisolone and Lenalidomide (RBP) In Refractory or Relapsed Multiple Myeloma. First Results of a Phase I Clinical Trial. Blood, Nov 2010; 116: 1971
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01701076
- Acronym / sponsor ID
- BRd / CTU10.041/BRd
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed / refractory multiple myeloma, 2nd line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Collaborators
- Celgene Corporation, Mundipharma Research GmbH & Co KG, Mundipharma Medical Company, Amgen
- Study start
- Mar 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Oct 2012 (estimated)
- 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.
Almost all patients with multiple myeloma who survive initial treatment will eventually relapse and require further therapy.
Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone until disease progression is therefore considered a standard therapy for second line treatment in multiple myeloma patients. However, only a relatively low rate of high quality response (CR, complete response and VGPR, very good partial response) is achieved. High quality responses are associated with with improved progression-free survival and overall survival [4].
Trial: The aim of this trial is to improve high quality response rates for patients with relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved by the addition a third anti-myeloma drug (bendamustine) to the established backbone of lenalidomide/ dexamethasone.
Treatment regimen:
- Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75years) d 1, 8, 15, 22.
- Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75 years) d 1, 8, 15, 22.
Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe neutropenia.
The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this aim is achieved, the treatment of bendamustine in combination with the established lenalidomide/ dexamethasone regimen will be considered promising.
Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.
Detailed description
Assessments for efficacy / response evaluation:
- M-protein quantitation in serum and 24 h urine collection samples by serum- and urine protein electrophoresis
- Quantitation of immunoglobulin levels by nephelometry
- Serum and urine immunofixation
- Free light chain concentrations and ratio in the serum
- Plasma cell percentage in the bone marrow by conventional cytology and biopsy with immunohistochemistry
- Radiologic assessments of the skeleton
Response criteria: Response will be assessed according to IMWG criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine | Experimental | Drug: BendamustineAll patients are treated with bendamustine in combination with lenalidomide and dexamethasone for a maximum of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Written informed consent
- Patients with first relapsed or refractory multiple myeloma (including patients with relapse after high dose chemotherapy followed by autologous stem cell transplantation) who have received no more than one prior line of anti-myeloma treatment
- Treatment with a lenalidomide/ dexamethasone-based 2nd-line regimen is indicated and intended
- Measurable disease as defined by at least one of the following 3 measurements
- ECOG performance status 0, 1, or 2
Key exclusion criteria (14 listed)
- Pregnant or breast feeding females
- Any prior use of bendamustine
- Patients who are unable or unwillingly to undergo antithrombotic therapy
- Any serious underlying medical condition (at the judgment of the investigator) which impairs the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorder)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she would participate in the study or any condition significantly confounding the ability to interpret data from the study, based on the local investigator's judgement
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 |
|---|---|---|
| BendamustineAlso: Lenalidomide, Dexamethasone, PegfilgrastimInduction treatment phase (cycle 1-6): * Bendamustine 75 mg/m2 i.v day 1 and 2 * Lenalidomide 25 mg p.o. day 1-21 * Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22 * Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia Maintenance treatment phase (cycles 7-18): * Lenalidomide 25 mg p.o. day 1-21 * Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22 | Drug | Bendamustine |
Primary outcome
Efficacy (combined CR-/VGPR-rate) achieved during the induction treatment phase or within four weeks after the last administration of six induction cycles of the BRd regimen
Time frame: Every 4 weeks up to 7 months
5 secondary outcomes
Objective response rates (sCR, CR, VGPR, PR, MR)
Time frame: Every 4 weeks up to 7 months
Best response (sCR, CR, VGPR, PR, MR)
Time frame: Every 4 weeks up to 36 months
Time to progression (TTP)
Time frame: Every 4 weeks up to 36 months
Overall survival (OS)
Time frame: Every 8 weeks up to 36 months
Safety and tolerability
Time frame: Every 4 weeks until 30 days after completion of study treatment
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 Aug 2016.
- Background: PubMed 18032763Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
- Background: PubMed 18032762Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
- Background: PubMed 19626046Dimopoulos MA, Chen C, Spencer A, Niesvizky R, Attal M, Stadtmauer EA, Petrucci MT, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Leukemia. 2009 Nov;23(11):2147-52. doi: 10.1038/leu.2009.147. Epub 2009 Jul 23.
- Background: PubMed 19638622Harousseau JL, Attal M, Avet-Loiseau H. The role of complete response in multiple myeloma. Blood. 2009 Oct 8;114(15):3139-46. doi: 10.1182/blood-2009-03-201053. Epub 2009 Jul 28.
- Background: PubMed 22451423Lentzsch S, O'Sullivan A, Kennedy RC, Abbas M, Dai L, Pregja SL, Burt S, Boyiadzis M, Roodman GD, Mapara MY, Agha M, Waas J, Shuai Y, Normolle D, Zonder JA. Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study. Blood. 2012 May 17;119(20):4608-13. doi: 10.1182/blood-2011-12-395715. Epub 2012 Mar 26.
- BackgroundPönisch W, Heyn S, Wagner I, et al. Combined Bendamustine, Prednisolone and Lenalidomide (RBP) In Refractory or Relapsed Multiple Myeloma. First Results of a Phase I Clinical Trial. Blood, Nov 2010; 116: 1971
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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.
Ulrich Mey, MD study chair
Kantonsspital Graubünden
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 Bendamustine in people with Multiple Myeloma, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 14 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 Aug 2016. 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 Switzerland. 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?
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?
Efficacy (combined CR-/VGPR-rate) achieved during the induction treatment phase or within four weeks after the last administration of six induction cycles of the BRd regimen (time frame: Every 4 weeks up to 7 months). 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 NCT01701076, which also lists 6 linked publications.
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 Aug 2016.