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NCT01374217 · REGISTRY CONDITION SEARCH

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2018-12-10

The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Progression

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outcome · POSTED

Quality of Life Scores

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outcome · POSTED

Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Progressive myeloma as defined by the International Uniform Criteria. * Currently on Lenalidomide and dexamethasone for the treatment of myeloma * Age \> 18 years. * Measurable paraprotein in serum or urine or detectable free light chains in the serum. * ECOG performance status of 0 - 2. Exclusion Criteria: * Hypersensitivity to PDE5 inhibitors such as tadalafil, sildenafil or vardenafil. * History of malignancy other than multiple myeloma in the last five years of, except adequately treated basal or squamous cell skin cancer. * Participation in any clinical trial which involved an investigational drug or device four weeks prior. * Infection requiring treatment with antibiotics, antifungal, or antiviral agents in the last seven days * Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). * History of significant hypotensive episode requiring hospitalization. * Acute myocardial infarction within prior 3 months, uncontrolled angina * Uncontrolled arrhythmia, or uncontrolled congestive heart failure * History of any of the following cardiac conditions: I. Angina requiring treatment with long-acting nitrates. II. Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration. III. Unstable angina within 90 days of visit 1. IV. Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention. \- History of any of the following coronary conditions within 90 days of planned tadalafil administration: i. Myocardial Infarction. ii. Coronary artery bypass graft surgery. iii. Percutaneous coronary intervention (for example, angioplasty or stent placement). iv. Any evidence of heart disease (NYHA≥Class III) within 6 months of planned tadalafil administration. * Current treatment with nitrates. * Current systemic treatment with a potent cytochrome P450 3A4 (CYP3A4) inhibitors such as ketoconazole or ritonavir. * Prior chronic immune suppressive state (AIDS, immunosuppressive therapy). * History of hypotension and/or blindness or sudden decrease/loss of hearing during prior treatment with PDE-5 inhibitors. * Prior history of non-arterial ischemic optic retinopathy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)
    intervention Names
    1. Drug: Tadalafil
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    4. Drug: Clarithromycin
    label
    Tadalafil
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Tadalafil
    description
    Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days
    name
    Tadalafil
    other Names
    1. Cialis
    type
    DRUG
  2. arm Group Labels
    1. Tadalafil
    description
    Lenalidomide will be administered as it was prior to study entry.
    name
    Lenalidomide
    other Names
    1. Revlimid
    type
    DRUG
  3. arm Group Labels
    1. Tadalafil
    description
    Dexamethasone will be administered as it was prior to study entry.
    name
    Dexamethasone
    other Names
    1. Decadron
    type
    DRUG
  4. arm Group Labels
    1. Tadalafil
    description
    Clarithromycin will be administered as it was prior to study entry.
    name
    Clarithromycin
    other Names
    1. Biaxin
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of participants who responded to the addition of tadalafil. Response is defined as a complete remission (CR), very good partial remission (VGPR), partial remission (PR), or stable disease (SD) by International Uniform Response criteria.
    measure
    Response Rate
    time Frame
    Up to 6 months
secondary Outcomes
  1. description
    Median length of response in months.
    measure
    Duration of Response
    time Frame
    Up to 6 months
  2. description
    Median time to progression of disease in days.
    measure
    Time to Progression
    time Frame
    Up to 71 days
  3. description
    Median change in symptom scores. Scale is the EORTC QLQ-C30. There are three domains: symptom scale (score range 7-14); past week (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.
    measure
    Quality of Life Scores
    time Frame
    3 months (M3) and 6 months (M6)
  4. description
    Percentage change in the amount of myeloid derived suppressor cells (MDSCs) in peripheral blood.
    measure
    Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification
    time Frame
    Up to 6 months
Full study description
brief Summary
The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.
detailed Description
This is an early phase study to evaluate the safety and efficacy of the combination of tadalafil with lenalidomide and dexamethasone (Rd) or BiRd. 19 patients on Rd or BiRd will be treated with tadalafil for a minimum of 6 months. The investigational drug will be discontinued if there is evidence of disease progression as defined by the International Uniform Response criteria \[1\]. For responding patients (patients who have a CR, VGPR, PR or SD), the therapy will be continued until progression or intolerable adverse effects. Blood and bone marrow will be collected for various studies as detailed in section 14.10. Clinical response will be monitored every month during the study.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      payload
      clinical indication matching status
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      id
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT01374217
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      20f1cdc5ebd705d0db96b905ae0e5429aba8ac1e2f3e5b8f44f8381c7b6c8bb5

    Preserved source evidence · Not medical advice