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Multiple MyelomaPhase 2NCT02219178

Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

A Phase 2 study testing lenalidomide, Subcutaneous bortezomib and Dexamethasone in people with Multiple Myeloma, run by Cancer Trials Ireland at 8 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the overall response rate after 4 cycles and the best response to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed 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?
lenalidomide, Subcutaneous bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
8 sitesIreland
Study dates
Nov 2014to Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Participants must have a diagnosis of symptomatic MM, according to International Myeloma Foundation 2003 Diagnostic Criteria:
  • Clonal plasma cells > 10% on bone marrow biopsy
  • A monoclonal protein (paraprotein) in either serum or urine ( except in the cases of non-secretory myeloma).
  • If no monoclonal protein is detected (non-secretory disease), then ≥ 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.
  • Evidence of end-organ damage felt related to the plasma cell disorder related organ or tissue impairment (ROTI), commonly referred to by the acronym 'CRAB':
  • Hypercalcaemia: serum calcium (corrected for albumin) > 10.5mg/sL/>2.65mmol/L or upper limit of normal
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  • Renal insufficiency defined as serum creatinine > 2mg/sL/177μmol/L
  • Anaemia: Normochromic, normocytic with a haemoglobin value > 2g/dL below the lower limit of normal or a haemoglobin < 10g/dL
  • Bone lesions (lytic lesions, severe osteopenia or pathologic fractures) as shown by CT scan and/or skeletal survey
  • Patient has received no prior treatment with any systemic therapy for the treatment of multiple myeloma.
  • Prior treatment of hypercalcaemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)
  • Bisphosphonates are permitted
  • Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible. Two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and 2 weeks have passed since the last date of therapy.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Age ≥ 18 years at the time of signing Informed Consent
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Lenalidomide Pregnancy Prevention Risk Management Plan. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL 10 to14 days prior to therapy and repeated again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Lenalidomide Pregnancy Prevention Risk Management Plan) and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy. All study participants must be registered into the mandatory Lenalidomide Pregnancy Prevention Risk Management Plan, and be willing and able to comply with the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.*A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. has had menses at any time during the preceding 24 consecutive months)
  • All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrolment
  • Subject has an ECOG performance status of < 2 or Karnofsky performance status of ≥ 60 (Appendix E).
  • Subject must be able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Patient has ≥ Grade 2 peripheral neuropathy on clinical examination within 14 days before enrolment
  • Renal insufficiency (serum creatinine levels > 2.5 mg/dL/221μmol/L, calculated creatinine clearance with Cockcroft-Gault formula (see Appendix G) < 45 ml/min)
  • Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e. unable to maintain a platelet count 50,000 cells/mm3)
  • Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm3. Growth factors may not be used to meet ANC eligibility criteria
  • Subjects with a haemoglobin < 8.0 g/dL
  • AST (SGOT) and ALT (SGPT) > 2 x ULN, bilirubin levels 1.5 ULN
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  • Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria)
  • Myocardial infarction within 6 months prior to enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix G), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Clinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals)
  • Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study.
  • Female subject is pregnant or breast-feeding
  • Serious psychiatric illness or addiction likely to interfere with participation in this clinical study
  • Uncontrolled diabetes mellitus
  • Contraindication to any required concomitant drugs or supportive therapies including hypersensitivity to all anticoagulation and antiplatelet options or hypersensitivity to acyclovir or similar anti-viral drug. History of allergic reaction/hypersensitivity attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dehydrate
  • POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
  • Known seropositive for or active HIV infection or active hepatitis B or C viral infection. Patients who are seropositive because of hepatitis B virus vaccine are eligible
  • Known intolerance to steroid therapy
  • Patient has hypersensitivity to bortezomib, boron, or mannitol
  • Diagnosed or treated for another malignancy within 2 years of enrolment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Participation in clinical trials with other anti-myeloma investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
  • Radiation therapy within 2 weeks before randomization. Enrolment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Ireland8 sites

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • St James's Hospital

    Dublin

  • University Hospital Galway

    Galway

  • University Hospital Limerick

    Limerick

  • Midlands Regional Hospital

    Tullamore

  • University Hospital Waterford

    Waterford, Co Waterford

Other trials in Ireland

About this study

Official title: A Phase II Study of the Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib, and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

This study aims to evaluate the overall response rate after 4 cycles and the best response to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.

Being tested
lenalidomide, Subcutaneous bortezomib, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called Revlimid

    25mg days 1 - 14 of 21 day schedule

  • Subcutaneous bortezomibDrug

    Also called Velcade

    1.3mg/m2 days 1, 4, 8, 11 of 21 day schedule

  • DexamethasoneDrug

    Also called Decadron

    20mg on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 day schedule

Study groups in NCT02219178
Study groupRoleWhat they receive
RsqVDExperimentalOral lenalidomide 25mg days 1 - 14 of 21 day schedule Subcutaneous bortezomib 1.3mg/m2 days 1, 4, 8, 11 of 21 day schedule Oral dexamethasone 20mg on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 day schedule
Receives: Drug: lenalidomide; Drug: Subcutaneous bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the overall response rate (ORR) after 4 induction cycles

    To evaluate the overall response rate (ORR) after 4 induction cycles and the best response to induction therapy with the combination of lenalidomide, subcutaneous (SQ) bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.

    Measured: After 4 cycles (84 days)

Secondary outcomes (4)

  1. a) To evaluate the rate and severity of Peripheral Neuropathy (PN) of SQ bortezomib in combination with lenalidomide, and dexamethasone after the 4th and after the final cycle of induction therapy.

    Evaluate the rate and severity of Peripheral Neuropathy of SQ bortezomib in combination with lenalidomide, and dexamethasone after the 4th and after the final cycle of induction therapy

    Measured: After 4 cycles (84 days)

  2. Progression of disease

    Evaluate the time to progression

    Measured: Duration of the study, expected to be approximately 3 years

  3. Progression free survival

    Evaluate progression free survival

    Measured: Duration of the study, expected to be approximately 3 years

  4. Duration of response

    Measured: Duration of the study, expected to be approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion31 Oct 2019
  4. Study completionApr 2020

Resources

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02219178
Sponsor's protocol ID
CTRIAL-IE (ICORG) 13-17
Other IDs
2013-005008-32
Status last verified
Jul 2020
First submitted
11 Aug 2014
Last updated
17 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • O'Gorman P, Laubach JP, O'Dwyer ME, Krawczyk J, Yee AJ, Gilligan O, Cahill MR, Rosenblatt J, Quinn J, Murphy PT, DiPietro H, Perera MR, Crotty GM, Cummings K, Hayden PJ, Browne P, Savell A, O'Leary HM, O'Keeffe D, Masone K, Hennessy BJ, Guerrero Garcia T, Scott K, Saeed K, Bianchi G, Dowling P, Tierney C, Richardson PG. Phase 2 studies of lenalidomide, subcutaneous bortezomib, and dexamethasone as induction therapy in patients with newly diagnosed multiple myeloma. Am J Hematol. 2022 May;97(5):562-573. doi: 10.1002/ajh.26491. Epub 2022 Feb 18.

    PubMed 35132679

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lenalidomide, Subcutaneous bortezomib and Dexamethasone in people with Multiple Myeloma, run by Cancer Trials Ireland at 8 sites in Ireland.

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 19 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: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Ireland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the overall response rate (ORR) after 4 induction cycles (time frame: After 4 cycles (84 days)). 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 NCT02219178, 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 17 Jul 2020.

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