Multiple MyelomaPhase 2NCT01374217
Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
A Phase 2 study testing Tadalafil, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. 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?
- Tadalafil, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jan 2014
- 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
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- Acute myocardial infarction within prior 3 months, uncontrolled angina
- Uncontrolled arrhythmia, or uncontrolled congestive heart failure
- History of any of the following cardiac conditions:
- Angina requiring treatment with long-acting nitrates. II. Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration.
- 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:
- Myocardial Infarction.
- Coronary artery bypass graft surgery.
- Percutaneous coronary intervention (for example, angioplasty or stent placement).
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
About this study
Official title: Administration of an Oral PDE5 Inhibitor, Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Tadalafil, Lenalidomide, Dexamethasone, Clarithromycin
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called Cialis
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
LenalidomideDrug
Also called Revlimid
Lenalidomide will be administered as it was prior to study entry.
DexamethasoneDrug
Also called Decadron
Dexamethasone will be administered as it was prior to study entry.
ClarithromycinDrug
Also called Biaxin
Clarithromycin will be administered as it was prior to study entry.
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd) Receives: Drug: Tadalafil; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
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.
Measured: Up to 6 months
Secondary outcomes (4)
Duration of Response
Median length of response in months.
Measured: Up to 6 months
Time to Progression
Median time to progression of disease in days.
Measured: Up to 71 days
Quality of Life Scores
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.
Measured: 3 months (M3) and 6 months (M6)
Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification
Percentage change in the amount of myeloid derived suppressor cells (MDSCs) in peripheral blood.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startApr 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: early stopping rule
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.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nilanjan Ghosh, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374217
- Sponsor's protocol ID
- J1167
- Other IDs
- NA_00049238
- Status last verified
- Nov 2018
- First submitted
- 13 Jun 2011
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of an Oral PDE5 Inhibitor, Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01374217
- Acronym / sponsor ID
- J1167
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: early stopping rule
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Posted 10 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: Tadalafil, Drug: Lenalidomide, Drug: Dexamethasone, Drug: ClarithromycinSubject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
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 |
|---|---|---|
| TadalafilAlso: CialisTadalafil 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 | Drug | Tadalafil |
| LenalidomideAlso: RevlimidLenalidomide will be administered as it was prior to study entry. | Drug | Tadalafil |
| DexamethasoneAlso: DecadronDexamethasone will be administered as it was prior to study entry. | Drug | Tadalafil |
| ClarithromycinAlso: BiaxinClarithromycin will be administered as it was prior to study entry. | Drug | Tadalafil |
Primary outcome
Response Rate
Time frame: Up to 6 months
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.
4 secondary outcomes
Duration of Response
Time frame: Up to 6 months
Time to Progression
Time frame: Up to 71 days
Quality of Life Scores
Time frame: 3 months (M3) and 6 months (M6)
Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Nilanjan Ghosh, M.D., Ph.D. principal investigator
Johns Hopkins 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 Tadalafil, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 5 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Dec 2018. 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 10 Dec 2018). 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?
Response Rate (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2018.