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Multiple Myeloma in RelapsePhase 2NCT01329289

SOM230 LAR With Bortezomib and Dexamethasone for Refractory or Relapsed Multiple Myeloma

A Phase 2 study testing SOM230, Bortezomib and Dexamethasone in people with Multiple Myeloma in Relapse and Multiple Myeloma, run by University of Pittsburgh at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine if adding SOM230 LAR to bortezomib and dexamethasone is better than bortezomib and dexamethasone alone and if it should be investigated further. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma in Relapse, Multiple Myeloma
What is being tested?
SOM230, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2011to Feb 2012
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

  • Patients must have histologically or cytologically confirmed symptomatic MM, Salmon-Durie Stage II or III, International Staging System II or III, or fulfill the CRAB criteria (see Appendix A, B). Patients should have previously been treated with at least one cycle of bortezomib, after which the patient has shown progressive or refractory disease. Finally, patients must meet at least one of the following parameters of measurable disease:
  • Bone marrow plasmacytosis with> 10% plasma cells, or sheets of plasma cells, or biopsy proven plasmacytoma which must be obtained within 6 weeks prior to registration.
  • Measurable levels of monoclonal protein (M-protein): ≥ 1 g/dL on serum protein electrophoresis (SPEP) or ≥ 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis (UPEP) or involved FLC ≥ mg/dL (≥ 100 mg/L) which must be obtained within 4 weeks prior to registration.
  • Serum and urine M-protein levels should be determined by electrophoresis rather than by quantitative immunoglobulin (Ig) measurement. Exceptions are made in cases in which the M-spike value may be deemed to be unreliable ( e.g. co-migrating M-spike). In these cases, quantitative Ig should be used. To assess response and progression, however, SPEP values should only be compared to SPEP values and quantitative Ig values only to quantitative Ig values.
  • Patients must have received at least two prior anti-MM treatments. The prior treatments must include at least one IMiD (thalidomide or lenalidomide) and bortezomib. If patients are unable to tolerate thalidomide or lenalidomide they can be included without prior IMiD treatment. Patients may be included if they did not experience grade III neuropathy while on bortezomib. Patients may have previously received autologous or peripheral blood stem cell transplantation.
  • Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy. Exception: e.g. kyphoplasty, vertebroplasty, local radiation therapy for symptomatic bone lesions (e.g., uncontrolled pain or high risk of pathologic fracture).
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  • Age ≥ 18 years.
  • Life expectancy of greater than 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%; see Appendix B).
  • Patients must have adequate organ and marrow function as defined below, obtained within 4 weeks prior to registration:
  • Hgb > 9 g/dL (which may be supported by transfusion or growth factors)
  • Absolute neutrophil count > 1000 x 10-9/L
  • Platelets ≥ 50,000 x 10-9/L
  • PT/PTT < 1.5 x upper limits of normal (ULN)
  • Total bilirubin ≤ 1.5 x (ULN)
  • Hepatic:
  • Serum bilirubin ≤ 1.5 ULN
  • Aspartate aminotransferase and alanine aminotransferase
  • 3 × ULN without liver metastases
  • 5 × ULN if documented liver infiltration
  • Renal:
  • Calculated creatinine clearance ≥40 ml/min according to the formula in Appendix D
  • Cholesterol* ≤ 300 mg/dL
  • Triglycerides (fasting)* ≤ 2.5 x ULN
  • Fasting plasma glucose (FPG)** < 1.5X ULN for FPG or HbA1c ≤ 8% *In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
  • At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
  • Patients must not be pregnant or breast feeding and must have a negative pregnancy test within 14 days of the administration of the first study treatment. Further, all women of childbearing potential and sexually active males must agree to use a medically effective contraception method throughout the treatment period and avoid conception while participating in this study. Women must not be lactating. Post menopausal patients and patients who had a bilateral oophorectomy need not take a pregnancy test.
  • Ability to understand and the willingness to sign a written informed consent document. Patient must be informed of the investigational nature of this study.
  • Patient should be able to swallow pills

Who cannot join

  • Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to entering the study or those who have not recovered from AEs due to chemotherapy, radiotherapy, or major surgery completed more than 4 weeks prior to registration. Exception: local radiation therapy for symptomatic bone lesions (e.g., uncontrolled pain or high risk of pathologic fracture).
  • Patients with any of the following cardiac abnormalities:
  • QTcF at screening > 450 msec
  • History of syncope or family history of idiopathic sudden death
  • Sustained or clinically significant cardiac arrhythmias
  • Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
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  • Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Concomitant medication(s) known to increase the QT interval
  • Diabetic patients on antidiabetic medications whose HbA1C > 8%
  • Patients currently receiving high dose systemic steroids for treatment of MM, patients without prior bortezomib treatment, patients who received an investigational agent within 5 half lives of the agent.
  • Patients who require therapeutic (full) anticoagulation such as full dose low molecular weight heparin or Coumadin with a goal INR of 2-3.
  • Patients with known brain metastases (treated or not) will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to SOM230 LAR and/or bortezomib or other agents used in the study.
  • Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
  • Patients with symptomatic cholelithiasis.
  • Patients previously treated with sst or sst analogues.
  • Patients with a second malignancy other than squamous/basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was curatively treated.
  • Known HIV infection
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Severely impaired lung function
  • Any active (acute or chronic) uncontrolled disorders
  • Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study therapy
  • Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice a medically effective method of birth control.
  • Inability to comply with study and/or follow-up procedures or history of medical noncompliance.
  • Patients who have a serious cardiac condition, such as myocardial infarction within 6 months, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, history of syncope, family history of idiopathic sudden death, QTc > 450 msec, advanced heart block or heart disease as defined by the New York Heart Association Class III or IV. (See ECG guidelines, Section 8.0).
  • Patients with non-secretory MM.
  • Patients with prior allogeneic transplantation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

The purpose of this study is to determine if adding SOM230 LAR to bortezomib and dexamethasone is better than bortezomib and dexamethasone alone and if it should be investigated further.

Being tested
SOM230, 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.

  • SOM230Drug

    Also called Pasireotide

    60 mg intramuscularly (IM) on day 1 of each 28 day cycle

  • BortezomibDrug

    Also called Velcade

    1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11 of each cycle. Bortezomib will be infused by IV push.

  • DexamethasoneDrug

    Also called Decadron, Dexasone, Diodex, Hexadrol

    20 mg orally on day of and day after bortezomib (Days 1, 2, 4, 5, 8, 9, 11, 12).

Study groups in NCT01329289
Study groupRoleWhat they receive
SOM230 with Bortezomib and DexamethasoneExperimentalNot described
Receives: Drug: SOM230; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

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

  1. Objective tumor response

    Responses (CR and PR) and incidence of SD will be tabulated by disease diagnosis. All responses will be reported. Response rate among patients with measurable disease will be summarized by exact binomial confidence intervals.

    Measured: 2 years

Secondary outcomes (6)

  1. progression-free survival

    The progression free survival function will be estimated by means of the product limit (Kaplan-Meier) esitmator with 95% confidence interval. Median PFS will be estimated from the survival function.

    Measured: 2 years

  2. Toxicities associated with this investigational combination

    Type, incidence severity (NCI-CTCAE grade), timing, relatedness of AE and laboratory abnormalities will be tabulated, with 95% confidence intervals, as appropriate.

    Measured: 2 years

  3. Effects of SOM230 LAR on PI3K/MAPK pathway

    Serum bone resorption markers, calcium, MIP-1alpha, TRACP-5b, serum (NTx), and serum C-terminal telopeptide (CTx) will be compared to circulating IGF-1 graphically (by scatterplots) and by Pearson or Spearman correlation coefficients, depending on the graphical assessment.

    Measured: 2 years

  4. Effect of bortezomib and SOM230 LAR on RANKL production and OCL formation

    Serum bone resorption markers will be measured during pretreatment and on day 1 of each cycle. Their change over time will be characterized by estimates derived from a mixed effects ANOVA model.

    Measured: 2 years

  5. IGF-1 inhibition and monitor circulating IGF-1

    To analyze whether bortezomib/SOM230 LAR treatment can restore the balance between OCL and osteoblast activity, bone marrow samples will be obtained before treatment and during treatment (day 11 of cycle 2) for OCL formation assays. Mean change over time will be estimated with 95% confidence intervals, and the null hypothesis of no change tested with a paired-comparison t-test

    Measured: 2 years

  6. Overall Survival

    Measured: 5-10 years

Timeline

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

  1. First posted5 Apr 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Why it stopped: Clinical trial being transferred to Columbia University with the Investigator.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329289
Sponsor's protocol ID
10-078
Status last verified
Feb 2016
First submitted
29 Mar 2011
Last updated
12 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOM230, Bortezomib and Dexamethasone in people with Multiple Myeloma in Relapse and Multiple Myeloma, run by University of Pittsburgh 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 29 inclusion and 27 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: withdrawn, as of the sponsor's last update on 12 Feb 2016. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Objective tumor response (time frame: 2 years). 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 NCT01329289.

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 12 Feb 2016.

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