Multiple MyelomaPhase 2T-BiRDNCT00538733
Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
A Phase 2 study testing thalomid, lenalidomide and clarithromycin in people with Multiple Myeloma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Study Objectives 1. Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). 2. 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?
- thalomid, lenalidomide and clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 17 Sep 2020
- 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).
- Newly diagnosed myeloma.
- No anti-myeloma 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 be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
- 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).
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- Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma.
- Able to take aspirin daily as prophylactic anticoagulation. (patients intolerant to ASA may use warfarin or low molecular weight heparin)
- 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 RevAssist® and the 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.
- 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, clarithromycin, 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 Thalidomide (THALOMID®), Clarithromycin (BIAXIN®), Lenalidomide(REVLIMID®), and Dexamethasone (DECADRON®) for Subjects With Newly Diagnosed Multiple Myeloma
Study Objectives
- Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
- Evaluate the efficacy of the addition of thalidomide (Thalomid®) to BiRD combination therapy as a therapy to increase the complete response rate for patients with newly diagnosed multiple myeloma.
- Evaluate the safety of the combination of clarithromycin, lenalidomide, dexamethasone, and thalidomide as a therapy for patients with newly diagnosed MM
Read the detailed description
This phase II study is a treatment program for patients with newly diagnosed multiple myeloma. Up to 25 patients will be enrolled. Patients who sign consent and fulfill all eligibility criteria will be enrolled to receive the following treatment plan:
T-BiRD Therapy:
Cycles 1-4
- Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)
- Clarithromycin (500mg twice daily for each 28 day cycle)
- Lenalidomide (25 mg daily days 1-21 of every 28 day cycle) and
- Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
- Prophylactic medications will be given.
After completing 4 cycles
- Patients who demonstrate progression of disease will be taken off study.
- Patients who achieve maximum response (either by achievement of complete remission or stable disease plateau) will be transitioned to maintenance therapy.
- Patients who achieve VGPR or PR with acceptable toxicity will be given T-BiRD for an additional 2 cycles: cycles 5 and 6.
Upon completion of 6 cycles of T-BiRD,
- Patients who achieve maximum response (either by achievement of complete remission or stable disease plateau) will be transitioned to maintenance therapy.
- Patients without disease progression or maximum response (either by achievement of complete remission or stable disease plateau) will receive BiRD therapy
- Patients with disease progression will be taken off study.
BiRD therapy will consist of the following:
- Clarithromycin (500mg twice daily for each 28 day cycle)*
- Lenalidomide (25mg daily days 1-21 of every 28 day cycle)*
- Dexamethasone (40mg on days 1, 8, 15, 22 of each 28 day cycle)*
- Prophylactic medications will be continued.
- Patients who finished T-BiRD therapy at reduced doses of clarithromycin, lenalidomide or dexamethasone will start BiRD therapy at the same doses of clarithromycin, lenalidomide and dexamethasone on which they ended T-BiRD therapy.
Patients who progress on BiRD will reinitiate T-BiRD as follows:
- Thalidomide (100mg/daily for days 1-28 for each 28 day cycle)
- Clarithromycin (500mg twice daily for each 28 day cycle)*
- Lenalidomide (25mg/daily for days 1-21 of each 28 day cycle)*
- Dexamethasone (40mg days 1, 8, 15, 22 of each 28 day cycle)*
- Prophylactic medications will be continued
- Patients who continue to show disease progression after two cycles of T-BiRD will be taken off study.
- Patients who finished BiRD therapy at reduced doses of clarithromycin, lenalidomide or dexamethasone will start T-BiRD therapy at the same doses of clarithromycin, lenalidomide and dexamethasone on which they ended BiRD therapy.
Transition to maintenance therapy:
Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in quantitative M-spike as detected on serum immunofixation) for > 2 cycles on either BiRD or T-BiRD therapy will be transitioned to maintenance therapy. Maintenance therapy will be comprised of:
- Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)*
- Lenalidomide 25 mg daily for days 1-21 out of a 28 day cycle. (15mg daily will be given days 1 - 21 out of a 28 day cycle to patients with a creatinine clearance of < 40cc / minute).*
- Prophylactic medications will be continued
- Patients who finished induction therapy with BiRD or T-BiRD at reduced doses lenalidomide or dexamethasone will start maintenance therapy at the same doses lenalidomide and dexamethasone 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.
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) and female of childbearing potential will have their pregnancy testing done, see APPENDIX III. 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
- thalomid, lenalidomide, clarithromycin, dexamethasone
- Keywords
- myeloma, newly diagnosed multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalomidDrug
Cycles 1-4
- Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)
lenalidomideDrug
During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)
- Lenalidomide (25 mg daily days 1-21 of every 28 day cycle)
During BiRD phase • 25mg daily days 1-21 of every 28 day cycle)
During Maintenance Phase
- 25 mg daily for days 1-21 out of a 28 day cycle
clarithromycinDrug
During T-BiRD Phase • Clarithromycin (500mg twice daily for each 28 day cycle)
During BiRD Phase:
- Clarithromycin (500mg twice daily for each 28 day cycle)
dexamethasoneDrug
During T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation)
- Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
During BiRD Phase:
- Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
During Maintenance Phase
- Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)
| Study group | Role | What they receive |
|---|---|---|
| T-BiRD Therapy | Experimental | All patients were treated with the same regimen, starting with T-BIRD therapy (Cycles 1-4).
After 4 cycles, Patients with disease progression will be taken off study. Patients who achieve maximum response will receive maintenance. Patients who achieve VGPR or PR will be given T-BiRD for 2 cycles (cycles 5-6). After 6 cycles of T-BiRD, Patients who achieve maximum response will receive maintenance; those with disease progression will be taken off study; all other patients will receive BIRD.
Patients who progress on BiRD will reinitiate T-BiRD. If disease progression continues after 2 cycles, patients will be taken off study.
Patients in CR/sCR or that achieve a plateau of disease for > 2 cycles on BiRD or T-BiRD therapy will receive maintenance. Receives: Drug: thalomid; Drug: lenalidomide; Drug: clarithromycin; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Drug Combination on Multiple Myeloma
Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
Measured: This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles
Secondary outcomes (3)
Median Time to Maximum Response
Median Time to maximum response, reported in cycles of treatment. One cycle = 28 days.
Measured: from baseline to cycle with maximum response
Event Free Survival
Measured: from baseline to the time of first event that lead to removal from study (defined as progression, death, withdrawal of consent, or removal for toxicity)
Progression Free Survival
Progression determined using International Myeloma Working Group criteria, as defined below.
An increase of > 25% from lowest response value one or more of the following:
- Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*
- Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
- Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL
- Bone marrow plasma cell percentage; the absolute percentage must be > 10%
- Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
- Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder *if starting serum M protein is greater then 5 g/dL, absolute increase of 1g/dL is sufficient to determine relapse.
Measured: From start of treatment, to the date of first progression
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 startOct 2007
- Primary completionJul 2010
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by 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
- 26 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
- NCT00538733
- Sponsor's protocol ID
- 0707009285
- Other IDs
- RV-MM-PI-238
- Acronym
- T-BiRD
- Status last verified
- Apr 2021
- First submitted
- 2 Oct 2007
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mark TM, Bowman IA, Rossi AC, Shah M, Rodriguez M, Quinn R, Pearse RN, Zafar F, Pekle K, Jayabalan D, Ely S, Coleman M, Chen-Kiang S, Niesvizky R. Thalidomide, clarithromycin, lenalidomide and dexamethasone therapy in newly diagnosed, symptomatic multiple myeloma. Leuk Lymphoma. 2014 Dec;55(12):2842-9. doi: 10.3109/10428194.2014.896005. Epub 2014 Mar 25.
PubMed 24576165
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Thalidomide (THALOMID®), Clarithromycin (BIAXIN®), Lenalidomide(REVLIMID®), and Dexamethasone (DECADRON®) for Subjects With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00538733
- Acronym / sponsor ID
- T-BiRD / 0707009285
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, newly diagnosed multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Oct 2007 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Posted 23 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
- Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
- Evaluate the efficacy of the addition of thalidomide (Thalomid®) to BiRD combination therapy as a therapy to increase the complete response rate for patients with newly diagnosed multiple myeloma.
- Evaluate the safety of the combination of clarithromycin, lenalidomide, dexamethasone, and thalidomide as a therapy for patients with newly diagnosed MM
Detailed description
This phase II study is a treatment program for patients with newly diagnosed multiple myeloma. Up to 25 patients will be enrolled. Patients who sign consent and fulfill all eligibility criteria will be enrolled to receive the following treatment plan:
T-BiRD Therapy:
Cycles 1-4
- Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)
- Clarithromycin (500mg twice daily for each 28 day cycle)
- Lenalidomide (25 mg daily days 1-21 of every 28 day cycle) and
- Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
- Prophylactic medications will be given.
After completing 4 cycles
- Patients who demonstrate progression of disease will be taken off study.
- Patients who achieve maximum response (either by achievement of complete remission or stable disease plateau) will be transitioned to maintenance therapy.
- Patients who achieve VGPR or PR with acceptable toxicity will be given T-BiRD for an additional 2 cycles: cycles 5 and 6.
Upon completion of 6 cycles of T-BiRD,
- Patients who achieve maximum response (either by achievement of complete remission or stable disease plateau) will be transitioned to maintenance therapy.
- Patients without disease progression or maximum response (either by achievement of complete remission or stable disease plateau) will receive BiRD therapy
- Patients with disease progression will be taken off study.
BiRD therapy will consist of the following:
- Clarithromycin (500mg twice daily for each 28 day cycle)*
- Lenalidomide (25mg daily days 1-21 of every 28 day cycle)*
- Dexamethasone (40mg on days 1, 8, 15, 22 of each 28 day cycle)*
- Prophylactic medications will be continued.
- Patients who finished T-BiRD therapy at reduced doses of clarithromycin, lenalidomide or dexamethasone will start BiRD therapy at the same doses of clarithromycin, lenalidomide and dexamethasone on which they ended T-BiRD therapy.
Patients who progress on BiRD will reinitiate T-BiRD as follows:
- Thalidomide (100mg/daily for days 1-28 for each 28 day cycle)
- Clarithromycin (500mg twice daily for each 28 day cycle)*
- Lenalidomide (25mg/daily for days 1-21 of each 28 day cycle)*
- Dexamethasone (40mg days 1, 8, 15, 22 of each 28 day cycle)*
- Prophylactic medications will be continued
- Patients who continue to show disease progression after two cycles of T-BiRD will be taken off study.
- Patients who finished BiRD therapy at reduced doses of clarithromycin, lenalidomide or dexamethasone will start T-BiRD therapy at the same doses of clarithromycin, lenalidomide and dexamethasone on which they ended BiRD therapy.
Transition to maintenance therapy:
Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in quantitative M-spike as detected on serum immunofixation) for > 2 cycles on either BiRD or T-BiRD therapy will be transitioned to maintenance therapy. Maintenance therapy will be comprised of:
- Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle)*
- Lenalidomide 25 mg daily for days 1-21 out of a 28 day cycle. (15mg daily will be given days 1 - 21 out of a 28 day cycle to patients with a creatinine clearance of < 40cc / minute).*
- Prophylactic medications will be continued
- Patients who finished induction therapy with BiRD or T-BiRD at reduced doses lenalidomide or dexamethasone will start maintenance therapy at the same doses lenalidomide and dexamethasone 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.
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) and female of childbearing potential will have their pregnancy testing done, see APPENDIX III. 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 |
|---|---|---|
| T-BiRD Therapy | Experimental | Drug: thalomid, Drug: lenalidomide, Drug: clarithromycin, Drug: dexamethasoneAll patients were treated with the same regimen, starting with T-BIRD therapy (Cycles 1-4). After 4 cycles, Patients with disease progression will be taken off study. Patients who achieve maximum response will receive maintenance. Patients who achieve VGPR or PR will be given T-BiRD for 2 cycles (cycles 5-6). After 6 cycles of T-BiRD, Patients who achieve maximum response will receive maintenance; those with disease progression will be taken off study; all other patients will receive BIRD. Patients who progress on BiRD will reinitiate T-BiRD. If disease progression continues after 2 cycles, patients will be taken off study. Patients in CR/sCR or that achieve a plateau of disease for > 2 cycles on BiRD or T-BiRD therapy will receive maintenance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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).
- Newly diagnosed myeloma.
- No anti-myeloma 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 be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
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 |
|---|---|---|
| thalomidCycles 1-4 • Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle) | Drug | T-BiRD Therapy |
| lenalidomideDuring T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation) • Lenalidomide (25 mg daily days 1-21 of every 28 day cycle) During BiRD phase • 25mg daily days 1-21 of every 28 day cycle) During Maintenance Phase • 25 mg daily for days 1-21 out of a 28 day cycle | Drug | T-BiRD Therapy |
| clarithromycinDuring T-BiRD Phase • Clarithromycin (500mg twice daily for each 28 day cycle) During BiRD Phase: • Clarithromycin (500mg twice daily for each 28 day cycle) | Drug | T-BiRD Therapy |
| dexamethasoneDuring T-BIRD Phase (Cycles 1-4, 5-6, and in the case of T-BIRD re-initiation) • Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle) During BiRD Phase: • Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle) During Maintenance Phase • Dexamethasone 20 mg weekly (days 1,8, 15, 22 out of a 28 day cycle) | Drug | T-BiRD Therapy |
Primary outcome
Effect of Drug Combination on Multiple Myeloma
Time frame: This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles
Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
3 secondary outcomes
Median Time to Maximum Response
Time frame: from baseline to cycle with maximum response
Event Free Survival
Time frame: from baseline to the time of first event that lead to removal from study (defined as progression, death, withdrawal of consent, or removal for toxicity)
Progression Free Survival
Time frame: From start of treatment, to the date of first progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24576165Mark TM, Bowman IA, Rossi AC, Shah M, Rodriguez M, Quinn R, Pearse RN, Zafar F, Pekle K, Jayabalan D, Ely S, Coleman M, Chen-Kiang S, Niesvizky R. Thalidomide, clarithromycin, lenalidomide and dexamethasone therapy in newly diagnosed, symptomatic multiple myeloma. Leuk Lymphoma. 2014 Dec;55(12):2842-9. doi: 10.3109/10428194.2014.896005. Epub 2014 Mar 25.
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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 thalomid, lenalidomide and clarithromycin 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 18 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: finished, as of the sponsor's last update on 24 May 2021. 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 23 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: This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles). 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 NCT00538733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.