Multiple MyelomaPhase 3BiRd vs RdNCT02516696
BiRd vs. Rd as Initial Therapy in Multiple Myeloma
A Phase 3 study testing Clarithromycin, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This is a randomized, open-label, phase III study to investigate the efficacy of combination therapy with an induction phase utilizing a combination clarithromycin (Biaxin®), lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are newly diagnosed and require treatment when compared to… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Clarithromycin, Lenalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to 22 Jul 2022
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject must voluntarily sign and understand written informed consent.
- Subject is at least 65 years old at the time of signing the consent form.
- Subject has histologically confirmed multiple myeloma that has never before been treated
- Subject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression.
- Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI.
- Subject has a Karnofsky performance status ≥60% (>50% if due to bony involvement of myeloma (see Appendix IV).
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- Subject is able to take prophylactic anticoagulation as detailed in section 9.1 (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
- Subject is registered into the mandatory RevAssist® program, and is willing and able to comply with the requirements of RevAssist® program.
- If subject is a female of childbearing potential (FCBP),† she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide
- Subject has a life expectancy ≥ 3 months
- Subjects must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L)
- Hemoglobin ≥ 7 g/dL
- Platelet count ≥ 30,000/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 total bilirubin <2.0 mg/dL (34 µmol/L)
- Creatinine clearance ≥ 45 cc/min
Who cannot join
- Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning).
- Subject has a prior history of other malignancies unless disease free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels.
- Subject has had myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure (see APPENDIX VI), Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Female subject who is pregnant or lactating.
- Subject has known HIV infection
- Subject has known active hepatitis B or hepatitis C infection.
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- Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Subject is unable to reliably take oral medications
- Subject has known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide
- Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment.
- Subject has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Subject has previously been treated for multiple myeloma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado - Anschutz Cancer Center
Aurora, Colorado, 80045
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma
This is a randomized, open-label, phase III study to investigate the efficacy of combination therapy with an induction phase utilizing a combination clarithromycin (Biaxin®), lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are newly diagnosed and require treatment when compared to patients who receive lenalidomide and dexamethasone alone.
Read the detailed description
This research study is for men and women with newly diagnosed, previously untreated multiple myeloma. The purpose of this study is to observe the how well the different combinations of study drugs work as therapy for patients with newly diagnosed, transplant ineligible, previously untreated multiple myeloma.
The study will be done in two arms:
BiRd Arm:
- Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle
- Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
- Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
Rd Arm:
- Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
- Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
Subjects will be treated in 28-day cycles and may continue treatment as long as they are responding to therapy and not experiencing unacceptable side effects or disease progression. There will be an evaluation at the end of each cycle. Participants will be in the study until disease progression or unacceptable toxicity.
- Conditions
- Multiple Myeloma
- Being tested
- Clarithromycin, Lenalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Also called biaxin
500mg PO twice daily on days 1-28 for a 28-day cycle.
LenalidomideDrug
Also called Revlimid
25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle
DexamethasoneDrug
Also called Decadron
20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
| Study group | Role | What they receive |
|---|---|---|
| BiRD treatment regimen | Experimental | Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Receives: Drug: Clarithromycin; Drug: Lenalidomide; Drug: Dexamethasone |
| Rd treatment regimen | Active comparator | Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Receives: Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Duration Without Disease Progression
Calculate rate of progression-free survival for subjects following treatment BiRd regimen compared to Rd treatment regimen. Progression is determined by the International Myeloma Working Group Criteria.
Measured: Until disease progression or death from any cause, for a maximum of approximately 5 years
Secondary outcomes (10)
Overall Response Rate
Capture the number of subjects who demonstrate a complete or partial response to treatment with BiRD regimen, as compared to Rd. Complete and partial responses are defined by the International Myeloma Working Group Criteria.
Measured: 2 years
Number of Adverse Events Experienced
Capture the number of adverse events experienced with BiRd regimen as compared to Rd regimen
Measured: 2 years
Overall Survival
Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.
Measured: 4 years
Number of Days After Initiating Treatment With BiRd Regimen to Disease Progression, as Compared to Subjects on Rd Treatment Regimen.
Progression is determined by the International Myeloma Working Group Criteria.
Measured: Until disease progression for a maximum of approximately 5 years
Number of Patients With Objective Response Rate (CR+PR)
Measured: up to 3 years
Number of Patients With Complete Response Rate (CR)
Complete response is defined by the International Myeloma Working Group Criteria.
Measured: up to 3 years
Number of Days for Event-Free Survival
Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms
Measured: approximately 5 years
Number of Days for Duration of Response
Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms
Measured: up to 3 years
Number of Months to Progression-Free Survival 2
Time from study entry until 2nd instance of disease progression. Progression is determined by the International Myeloma Working Group Criteria. Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
Measured: approximately 5 years
Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The FACIT- Fatigue Subscore (FS) is comprised of 13 items, within the total 40-item FACIT-F, that assess fatigue and its impact. This analysis is only based on the FS score. Items are scored on a 5 point Likert-type scale. Item scores can range from 0 ("not at all") to 4 ("very much"), and the total, summed score from 0 to 52; lower scores indicate greater fatigue. The recall period for each item is the past 7 days. Data is descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startFeb 2016
- Primary completion22 Jun 2022
- Study completion22 Jul 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Jorge Monge, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516696
- Sponsor's protocol ID
- 1411015662
- Other IDs
- RV-CL-MM-PI-004078
- Acronym
- BiRd vs Rd
- Status last verified
- Jun 2023
- First submitted
- 4 Aug 2015
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02516696
- Acronym / sponsor ID
- BiRd vs Rd / 1411015662
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2016 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, phase III study to investigate the efficacy of combination therapy with an induction phase utilizing a combination clarithromycin (Biaxin®), lenalidomide (Revlimid®), dexamethasone (Decadron®), in multiple myeloma patients who are newly diagnosed and require treatment when compared to patients who receive lenalidomide and dexamethasone alone.
Detailed description
This research study is for men and women with newly diagnosed, previously untreated multiple myeloma. The purpose of this study is to observe the how well the different combinations of study drugs work as therapy for patients with newly diagnosed, transplant ineligible, previously untreated multiple myeloma.
The study will be done in two arms:
BiRd Arm:
- Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle
- Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
- Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
Rd Arm:
- Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
- Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
Subjects will be treated in 28-day cycles and may continue treatment as long as they are responding to therapy and not experiencing unacceptable side effects or disease progression. There will be an evaluation at the end of each cycle. Participants will be in the study until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiRD treatment regimen | Experimental | Drug: Clarithromycin, Drug: Lenalidomide, Drug: DexamethasoneSubjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. |
| Rd treatment regimen | Active comparator | Drug: Lenalidomide, Drug: DexamethasoneSubjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Subject must voluntarily sign and understand written informed consent.
- Subject is at least 65 years old at the time of signing the consent form.
- Subject has histologically confirmed multiple myeloma that has never before been treated
- Subject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression.
- Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI.
Key exclusion criteria (12 listed)
- Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning).
- Subject has a prior history of other malignancies unless disease free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels.
- Subject has had myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure (see APPENDIX VI), Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Female subject who is pregnant or lactating.
- Subject has known HIV infection
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 |
|---|---|---|
| ClarithromycinAlso: biaxin500mg PO twice daily on days 1-28 for a 28-day cycle. | Drug | BiRD treatment regimen |
| LenalidomideAlso: Revlimid25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle | Drug | BiRD treatment regimen, Rd treatment regimen |
| DexamethasoneAlso: Decadron20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger. | Drug | BiRD treatment regimen, Rd treatment regimen |
Primary outcome
Survival Duration Without Disease Progression
Time frame: Until disease progression or death from any cause, for a maximum of approximately 5 years
Calculate rate of progression-free survival for subjects following treatment BiRd regimen compared to Rd treatment regimen. Progression is determined by the International Myeloma Working Group Criteria.
10 secondary outcomes
Overall Response Rate
Time frame: 2 years
Number of Adverse Events Experienced
Time frame: 2 years
Overall Survival
Time frame: 4 years
Number of Days After Initiating Treatment With BiRd Regimen to Disease Progression, as Compared to Subjects on Rd Treatment Regimen.
Time frame: Until disease progression for a maximum of approximately 5 years
Number of Patients With Objective Response Rate (CR+PR)
Time frame: up to 3 years
Number of Patients With Complete Response Rate (CR)
Time frame: up to 3 years
Number of Days for Event-Free Survival
Time frame: approximately 5 years
Number of Days for Duration of Response
Time frame: up to 3 years
Number of Months to Progression-Free Survival 2
Time frame: approximately 5 years
Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment
Time frame: up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- 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.
Jorge Monge, MD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clarithromycin, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 2 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 18 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: stopped early, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Jun 2023). 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?
Survival Duration Without Disease Progression (time frame: Until disease progression or death from any cause, for a maximum of approximately 5 years). 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 5 Jun 2023.