Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Stopped early · Phase 1

Conditions studied: Multiple Myeloma in Relapse

In brief

This study is being conducted to test the possibility that a combination of three drugs, pomalidomide and everolimus with dexamethasone, may improve patient responses when compared with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.

Key facts

Study ID

NCT01889420

Run by

New Mexico Cancer Research Alliance

People needed

1

Starts

2014-07-01

Expected to finish

2015-07-01

Last updated by the study team

2015-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Relapsed or progressive multiple myeloma (MM) (Progressive Disease), defined as a 25% increase from the lowest response value in ANY of the following:
• Serum M-protein (absolute increase ≥0.5 g/dL)
• Urine M-protein (absolute increase of ≥200 mg/24 hours)
• Bone marrow plasma cell percentage (≥ 10% absolute increase) in absence of measurable M-protein
• Difference in kappa \& lambda free light chain levels (ratio must be abnormal; absolute change must be >10 mg/dL)
• Patients are also considered to have progressive disease when:
• New bone or soft tissue lesions (e.g. plasmacytomas) are identified; or
• There is an unequivocal increase in the size of previously existing lesions; or
• The development of an otherwise unexplained serum calcium >11.5 mg/dL
• Have received 1, but no more than 4 prior treatment regimens or lines of therapy for MM (Induction therapy followed by stem cell transplant \& consolidation/maintenance therapy will be considered as one line of therapy)
• ECOG Performance status 0 - 2
• Life expectancy of at least 12 weeks
• Evaluable MM with, at least one of the following, assessed within 21 days prior to randomization:
• Serum M-protein ≥ 0.5 g/dL, or Urine M-protein ≥ 200 mg/24 hour, or
• In absence of detectable serum or urine M-protein, serum FLC (SFLC) > 100 mg/L (involved light chain) and/or an abnormal kappa/lamda ratio (>4:1 or <2:1), or
• Monoclonal plasma cells in a bone marrow biopsy/aspirate of >5%
• Adequate organ and marrow function as defined below:
• Leukocytes ≥ 2,500/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin < 2 X ULN
• AST(SGOT)/ALT(SPGT) ≤ 2.5 X ULN
• Creatinine < 1.5 X ULN
• Contraception Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for duration of study, and for 90 days after completion of therapy.

You may not qualify if…

• Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Receiving any other investigational agents. Minimum 4 week "washout" period is required.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide, everolimus, or other agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or nursing (due to the rick for congenital abnormalities and the potential of this regimen to harm nursing infants).
• Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• Plasma cell leukemia or circulating plasma cells ≥ 2 × 10\^9/L.
• Waldenstrom's Macroglobulinemia.
• Patients with known amyloidosis.
• Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
• Immunotherapy within 21 days prior to randomization.
• Myelodysplastic syndrome
• Major surgery (excluding kyphoplasty) within 28 days
• Known cirrhosis.
• Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days
• Ongoing graft-vs-host disease.
• Using CYP3A4 inhibitors such as Ketoconazole, Ritonavir, Itraconazole, Erythromycin, Clarithromycin, Nelfinavir, Fluconazole, Amiodarone, Cyclosporine, Diltiazem, nefazadone,fluvoxamine, verapamil, chloramphenicol, Indinavir or saquinavir within 7 days of treatment.

Where it is running

• UNM Cancer Research and Treatment Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.