Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Placebo-controlled Phase II Study of Clarithromycin or Placebo Combined With VCD Induction Therapy Prior to High-dose Melphalan With Stem Cell Support in Patients With Newly Diagnosed Multiple Myeloma
Brief Summary: This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.


Options:
A: Inclusion Criteria:

* Myeloma diagnosis according to IMWG criteria
* Treatment demanding disease
* High-dose melphalan with stem cell support scheduled as a part of the treatment
* Signed informed consent given prior to any study related activities
* Age \> 18 years

Exclusion Criteria:

* Allogeneic transplantation scheduled as a part of the treatment
* Myeloma treatment prior to entry in the study, except radiotherapy, bisphosphonates/denosumab or corticosteroids for symptom control
* Concurrent disease making clarithromycin treatment unsuitable
* Positive pregnancy test (only applicable for women with childbearing potential)
* Known or suspected hypersensitivity or intolerance to clarithromycin
* Prolonged QT corrected (QTc) interval ( \> 500 msec on screening ECG)
* Concurrent treatment with cabergoline, fluconazole, ketoconazole, pimozide, quetiapine, sirolimus, verapamil, tacrolimus, ergot alkaloid, simvastatin or other statins
* Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, uncontrolled angina or known cardiac amyloidosis
* Severe renal dysfunction (estimated creatinine clearance \<10 mL/min)
* Serious medical or psychiatric illness which, in the judgment of the investigator, would make the patient inappropriate for entry into the study
B: Inclusion Criteria:

* Clinical diagnosis of at least moderate Chronic Obstructive Pulmonary Disease (COPD), as defined by the following Global Initiative for COPD (GOLD) criteria:

  1. Post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than 70%
  2. Post-bronchodilator FEV1 less than 80% predicted, with or without chronic symptoms
* Cigarette consumption of 10 pack-years or more (may or may not be active smokers)
* Meets one or more of the following four conditions:

  1. Current, or history of, supplemental O2 use
  2. Received a course of systemic corticosteroids for respiratory problems within 1 year prior to study entry
  3. Visited an emergency department for a COPD exacerbation within 1 year prior to study entry
  4. Hospitalized for a COPD exacerbation within 1 year prior to study entry
* Willing to make return visits
* Available by telephone for duration of study
* Minimum of 4 weeks from the most recent acute exacerbation (have not received a course of systemic corticosteroids, an increased dose of chronically administered systemic corticosteroids, and/or antibiotics for an acute exacerbation for a minimum of 4 weeks from the time of study entry)

Exclusion Criteria:

* Diagnosis of asthma
* Diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy less than 3 years
* Special patient groups (i.e., prisoners, pregnant women, or institutionalized patients)
* Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (i.e., hormone-based oral or barrier contraceptive) for the duration of the study
* History of hypersensitivity to any macrolide antibiotic
* Taking any of the following medications:

  1. Cisapride
  2. Ergot derivatives
  3. Pimozide
  4. Disopyramide
  5. Cyclosporin
  6. Tacrolimus
  7. Nelfinavir
  8. Bromocriptine
  9. Hexobarbital
* Corrected QT interval (QTc) on electrocardiogram exceeding 440 ms
* Taking rifabutin or rifampin
* Chronic hepatic insufficiency
* Chronic renal insufficiency
* Diagnosis of bronchiectasis (defined as production of greater than one-half cup of purulent sputum/day)
* If, for either ear, formal audiometric testing in a sound booth results in a pure tone average (i.e., the average of the thresholds for the 4 frequencies 1000, 2000, 3000, or 4000) exceeding 50 decibel (dB), or if the threshold at any one frequency exceeds 60 dB, then the participant will be counseled by the audiologist concerning hearing aids and/or referral to an otolaryngologist. In addition, the audiologist may discuss with the participant whether or not to continue in the study. Following the examination and counseling, the participant will also discuss whether or not to continue in the study with one of the study investigators. If it is found that a participant's pure tone average in the two ears differs by more than 15 dB, or if the difference in the two ears for any one frequency exceeds 20 dB, then the participant will not be eligible for randomization into the study unless cleared by an otolaryngologist
C: Inclusion Criteria:

* patients aged 18 to 85 years and
* previous acute myocardial infarction (AMI) or
* previous or present angina pectoris and
* signed informed concent

Exclusion Criteria:

* AMI or unstable angina pectoris within the last three months
* revascularisation (PTCA or CABG) within the preceding six months
* severe heart failure (New York Heart Association (NYHA) functional class IV)
* known impaired renal or hepatic function
* active malignancy
* intolerance to macrolides
* treatment with methylxanthines, carbamazepine, cisapride, astemizole, terfenadine, or coumarin anticoagulants
* earlier inclusion in the CLARICOR Trial or participation in another drug trial within four weeks
* participation in other clinical trials within one month before this trial
* individuals incapable of managing own affairs or not able to sign written consent
* lack of written consent
* women of childbearing age not using reliable contraceptives
* breast feeding women
D: Inclusion Criteria:

* Have provided written informed consent to participate in the study in accordance with the local ethics committee regulations
* Have a confirmed diagnosis of bronchiectasis (by HRCT) Aged 18 years or over Have chronic sputum production, defined as a greater than 45 mililitres volume produced in the 1 week prior to study entry.
* Be able to perform reproducible spirometry
* Be in a relatively stable disease state in the 6 weeks prior to entry, as defined by the absence of the following: respiratory exacerbations requiring hospitalisation, change in cough and/or sputum production, new or increased hemoptysis, more than 10% weight loss, use of additional antibiotic courses

Exclusion Criteria:

* Subjects will be excluded if one or more of the following criteria occur. The subject: Is an investigator, or an immediate family member of an investigator
* Has a confirmed diagnosis of cystic fibrosis, as evidenced by genetic analysis or a sweat test result more than 60mmol/L
* Has a primary immunodeficiency Is a pregnant or lactating female Has had a respiratory exacerbation requiring hospitalisation or additional course of antibiotics in the 6 weeks prior to study entry
* Has been prescribed or used oral steroids on any occasion for the 3 months prior to study entry.
* Has been using mucolytic agents on any occasion for the 2 months prior to study entry Has active tuberculosis
* Has an active malignancy, including melanoma (other skin carcinomas excluded)
* Has a history of significant liver disease or insufficiency Has a significant history of drug abuse (including alcohol abuse) or mental illness Has a known intolerance or allergy to macrolides
* Has been participating in another interventional drug study in the 3 months prior to enrolment into this study

Answer: A