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Trial record 62 of 372 for:    LENALIDOMIDE AND Dexamethasone

Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04063189
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
FengYan Jin, First Hospital of Jilin University

Brief Summary:
BiRd regimen consisting of clarithromycin and Rd is safe and effective in NDMM. It can significantly increase ORR (up to 90.3%) , relief depth (≥VGPR), and prolong PFS to 43 months. In our previous study, thirty RRMM patients treated with BiRd regimen in 6 centers in China benefited.It suggested that BiRd regimen may not only improve overall efficacy of RRMM , especially long-term benefits, but also reverse Rd resistance in patients who fail to achieve any remission after multiline therapy.The study is a Prospective, Multicenter, Single Arm, Phase II Clinical Trial, which intend to recruit first relapse MM patients over 18 years old. Once included, patients will receive the treatment of Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen. (Clarithromycin 500mg,po,bid,d1-21; Lenalidomide 25mg,po,daily,d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg,po,daily,d1-2, 8-9,15-16, 22-23) And we will evaluate efficacy and adverse events of the BiRd regimen at a point of time predetermined.

Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Drug: Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single Arm, Phase II Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone (BiRd Regimen) in the Treatment of the First Relapsed Multiple Myeloma
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020


Arm Intervention/treatment
Experimental: First Relapsed Multiple Myeloma Drug: Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen
Clarithromycin 500mg,po,bid,d1-21; Lenalidomide 25mg,po,daily,d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg,po,daily,d1-2, 8-9,15-16, 22-23




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Every 2 months until disease progression or study completion,an average of 2 year ]
    According to the criteria of IMWG 2016


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v4.03 [ Time Frame: Through study completion,an average of 2 year ]
    According to NCI-CTCAE version 4.03

  2. Progression-Free Survival (PFS) [ Time Frame: Through study completion, an average of 2 year ]
    PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death

  3. Overall Survival (OS) [ Time Frame: Through study completion, an average of 2 year ]
    OS were calculated from the time of enrollment to death or the last follow-up

  4. Duration of Response (DOR) [ Time Frame: Through study completion, an average of 2 year ]
    the time from the first assessment of CR (complete response) or PR (partial response) to the first PD (Progressive Disease) or any cause of death


Other Outcome Measures:
  1. Health-Related Quality of Life (HRQoL) [ Time Frame: Every 6 months until disease progression or study completion,an average of 2 year ]
    According to the data of SF-36 Quality of Life Questionnaire Survey



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosed as symptomatic multiple myeloma.
  2. the first relapse/progression with thalidomide, bortezomib or lenalidomide based current first-line treatment or resistance to the first-line treatment (previous treatment line number =1).
  3. there must be measurable lesions to determine disease progression (PD): according to the IMWG 2016 efficacy evaluation criteria.
  4. the expected survival time is longer than 3 months.
  5. ECOG score less than 2 points.
  6. the serum AST/ALT level <3 times higher than the normal value; the serum total bilirubin level<2 times of the normal value; creatinine clearance rate was ≥30ml/mi.
  7. neutrophil count >1000/mm3 ; platelet count >75000/mm3 (if bone marrow plasma cell <50%) or >30000/mm3 (if the plasma cells in the bone marrow is not less than 50%).
  8. women of childbearing age were negative for pregnancy before admission, and agreed to carry out pregnancy screening during the study (once a month until 4 weeks after the last dose), and agreed to use contraceptive measures within 3 months after the study and the last dose.
  9. all patients were required to sign informed consent.

Exclusion Criteria:

  1. under the age of 18
  2. ECOG score >2
  3. non secretory myeloma, defined as serum protein M < 1g/dL, urinary M protein < 200mg/24h and sFLCR ≤100mg/L
  4. there is growing demand, pregnant or lactating women within one year
  5. HIV infection
  6. activity of HBV or HCV infection
  7. 4 weeks before entering the group of thromboembolic events
  8. not signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063189


Contacts
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Contact: Fengyan Jin, professor 13844989638 fengyanjin@jlu.edu.cn

Locations
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China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Fengyan Jin, Professor    +8613844989638    fengyanjin@jlu.edu.cn   
Sponsors and Collaborators
First Hospital of Jilin University
Investigators
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Study Director: Fengyan Jin, professor First Hospital of Jilin University

Publications:

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Responsible Party: FengYan Jin, MD, PHD, Physician in Charge of Hematology Department, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT04063189     History of Changes
Other Study ID Numbers: BiRd 2017-288-1
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by FengYan Jin, First Hospital of Jilin University:
Clarithromycin Lenalidomide Dexamethasone Regimen
Treatment Response
Survival
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Clarithromycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents