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TerminatedNCT02516696BiRd vs RdUpdated Jun 5, 2023Results posted

BiRd vs. Rd as Initial Therapy in Multiple Myeloma

A Phase 3 interventional study of Clarithromycin and Lenalidomide in Multiple Myeloma, sponsored by Weill Medical College of Cornell University. Terminated at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Weill Medical College of Cornell University · Phase 3, Interventional, and Treatment

Why this study was terminated
low enrollment
Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 12 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    BiRD treatment regimen

    Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles.

    Drug: Clarithromycin · Drug: Lenalidomide · Drug: Dexamethasone

  • Active comparator
    Rd treatment regimen

    Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles.

    Drug: Lenalidomide · Drug: Dexamethasone

Interventions

  • DrugClarithromycin

    500mg PO twice daily on days 1-28 for a 28-day cycle.

    Also known as: biaxin

  • DrugLenalidomide

    25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle

    Also known as: Revlimid

  • DrugDexamethasone

    20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.

    Also known as: Decadron

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Until disease progression or death from any cause, for a maximum of approximately 5 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. Number of Adverse Events Experienced

    Capture the number of adverse events experienced with BiRd regimen as compared to Rd regimen

    Time frame: 2 years

  3. Overall Survival

    Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.

    Time frame: 4 years

  4. 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.

    Time frame: Until disease progression for a maximum of approximately 5 years

  5. Number of Patients With Objective Response Rate (CR+PR)

    Time frame: up to 3 years

  6. Number of Patients With Complete Response Rate (CR)

    Complete response is defined by the International Myeloma Working Group Criteria.

    Time frame: up to 3 years

  7. Number of Days for Event-Free Survival

    Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms

    Time frame: approximately 5 years

  8. Number of Days for Duration of Response

    Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms

    Time frame: up to 3 years

  9. 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.

    Time frame: approximately 5 years

  10. 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.

    Time frame: up to 3 years

07

Results

Posted Jun 5, 2023
Limitations and caveats
The significance of these results is limited by the study's low accrual. The study's low accrual was due in part to the COVID-19 pandemic.

Participant flow

Participant flow — Overall Study
MilestoneBiRD Treatment RegimenRd Treatment Regimen
Started75
Completed75
Not completed00

Outcome measures

PrimarySurvival 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.

Time frame:
Until disease progression or death from any cause, for a maximum of approximately 5 years
Reported as:
Median · days
Survival Duration Without Disease Progression
daysBiRD Treatment RegimenRd Treatment Regimen
Survival Duration Without Disease Progression661 (586 to NA)1694 (821 to NA)
SecondaryOverall 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.

Time frame:
2 years
Reported as:
Count of participants · Participants
Overall Response Rate
ParticipantsBiRD Treatment RegimenRd Treatment Regimen
Overall Response Rate74
SecondaryNumber of Adverse Events Experienced

Capture the number of adverse events experienced with BiRd regimen as compared to Rd regimen

Time frame:
2 years
Reported as:
Number · adverse events
Number of Adverse Events Experienced
adverse eventsBiRD Treatment RegimenRd Treatment Regimen
Number of Adverse Events Experienced7967
SecondaryOverall Survival

Survival following treatment to the date of death of subjects on BiRd regimen as compared to Rd.

Time frame:
4 years
Reported as:
Median · days
Overall Survival
daysBiRD Treatment RegimenRd Treatment Regimen
Overall SurvivalNA (906 to NA)1014 (821 to NA)
SecondaryNumber 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.

Time frame:
Until disease progression for a maximum of approximately 5 years
Reported as:
Median · days
Number of Days After Initiating Treatment With BiRd Regimen to Disease Progression, as Compared to Subjects on Rd Treatment Regimen.
daysBiRD Treatment RegimenRd Treatment Regimen
Number of Days After Initiating Treatment With BiRd Regimen to Disease Progression, as Compared to Subjects on Rd Treatment Regimen.661 (661 to NA)1694 (NA to NA)
SecondaryNumber of Patients With Objective Response Rate (CR+PR)
Time frame:
up to 3 years
Reported as:
Count of participants · Participants
Number of Patients With Objective Response Rate (CR+PR)
ParticipantsBiRD Treatment RegimenRd Treatment Regimen
Number of Patients With Objective Response Rate (CR+PR)74
SecondaryNumber of Patients With Complete Response Rate (CR)

Complete response is defined by the International Myeloma Working Group Criteria.

Time frame:
up to 3 years
Reported as:
Count of participants · Participants
Number of Patients With Complete Response Rate (CR)
ParticipantsBiRD Treatment RegimenRd Treatment Regimen
Number of Patients With Complete Response Rate (CR)20
SecondaryNumber of Days for Event-Free Survival

Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms

Time frame:
approximately 5 years
Reported as:
Median · days
Number of Days for Event-Free Survival
daysBiRD Treatment RegimenRd Treatment Regimen
Number of Days for Event-Free Survival336 (225 to NA)821 (310 to NA)
SecondaryNumber of Days for Duration of Response

Descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms

Time frame:
up to 3 years
Reported as:
Median · days
Number of Days for Duration of Response
daysBiRD Treatment RegimenRd Treatment Regimen
Number of Days for Duration of Response308 (227 to NA)803 (282 to NA)
SecondaryNumber 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.

Time frame:
approximately 5 years

No measurements were reported for this outcome.

SecondaryFunctional 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.

Time frame:
up to 3 years
Reported as:
Mean · Score on a scale
Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment
Score on a scaleBiRD Treatment RegimenRd Treatment Regimen
Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment32.75 (16.9 to 45.46)37.24 (28.58 to 45.89)

Adverse events

Collected over Adverse events were collected from the time of informed consent until participants were removed from the study, or for a maximum of 60 months. Participants were removed at the time of disease progression, death, or study termination, whichever occurred first. This study was terminated early due to low accrual.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BiRD Treatment Regimen2/7 (28.6%)6/7 (85.7%)7/7 (100%)
Rd Treatment Regimen4/5 (80%)3/5 (60%)5/5 (100%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventBiRD Treatment RegimenRd Treatment Regimen
FallGeneral disorders2/71/5
SyncopeGeneral disorders2/70/5
ConstipationGastrointestinal disorders0/71/5
Secondary Primary MalignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/71/5
DyspneaRespiratory, thoracic and mediastinal disorders0/71/5
Acute Kidney InjuryRenal and urinary disorders0/71/5
Atrial FibrillationCardiac disorders0/71/5
Edema LimbsGeneral disorders0/71/5
Skin InfectionSkin and subcutaneous tissue disorders0/71/5
COVID-19 InfectionInfections and infestations0/71/5
Most frequent other events
Showing 10 of 60
Most frequent other events
EventBiRD Treatment RegimenRd Treatment Regimen
ConstipationGastrointestinal disorders3/71/5
DiarrheaGastrointestinal disorders3/72/5
FatigueGeneral disorders3/72/5
AnorexiaGeneral disorders1/72/5
DyspneaRespiratory, thoracic and mediastinal disorders1/72/5
DyspepsiaGastrointestinal disorders1/72/5
Edema LimbsGeneral disorders2/72/5
PainGeneral disorders2/72/5
Maculo-papular rashSkin and subcutaneous tissue disorders2/72/5
Weight LossGeneral disorders0/72/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)BiRD Treatment RegimenRd Treatment RegimenTotal
<=18 years000
Between 18 and 65 years000
>=65 years7512
Sex: Female, Male
Sex: Female, Male(Participants)BiRD Treatment RegimenRd Treatment RegimenTotal
Female527
Male235
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BiRD Treatment RegimenRd Treatment RegimenTotal
Hispanic or Latino000
Not Hispanic or Latino7411
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BiRD Treatment RegimenRd Treatment RegimenTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American213
White426
More than one race000
Unknown or Not Reported123
Region of Enrollment
Region of Enrollment(participants)BiRD Treatment RegimenRd Treatment RegimenTotal
United States7512
08

Study locations

2 sites
  • University of Colorado - Anschutz Cancer Center
    Aurora, Colorado 80045, United States
  • Weill Cornell Medical College
    New York, New York 10065, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 22, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02516696
Lead sponsor
Weill Medical College of Cornell University
Collaborators
Celgene Corporation
Responsible party
Sponsor
First posted
Aug 6, 2015
Start date
Feb 2016
Primary completion
Jun 22, 2022
Completion
Jul 22, 2022
Results posted
Jun 5, 2023
Last update
Jun 5, 2023

Study contacts

Jorge Monge, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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