CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Pomalidomide; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Symptomatic multiple myeloma

• Previously treated disease meeting one of the following criteria:

• Have light-chain amyloidosis that has been treated with at least one prior regimen

• Symptomatic (relapsed or refractory) multiple myeloma

• Patients must have received 1-3 treatment regimens

• Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen

• Measurable disease, as defined by 1 of the following:

• Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

• More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis

• Serum immunoglobulin free light chain (FLC) > 10 mg/dL and an abnormal FLC ratio

• Measurable soft tissue plasmacytoma, not previously irradiated

• More than 30% plasma cells in bone marrow

• At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index

• No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid)

• No smoldering myeloma (not applicable for patients with amyloid)

PATIENT CHARACTERISTICS:

• ECOG performance status 0, 1, or 2

• ANC ≥ 1,000/μL

• Platelet count ≥ 75,000/μL

• Creatinine ≤ 2.5 mg/dL

• Not pregnant or nursing

• Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug

• Negative pregnancy test

• Fertile female patients must use two reliable forms of contraception simultaneously at least 28 days before beginning, during, and at least 28 days after completion of study drug

• The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, or partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, or cervical cap)

• Fertile male patients must use a latex condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment

• Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug

• Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug

• No uncontrolled infection

• No other active malignancy

• No New York Heart Association class III or IV cardiac disease (all patients)

• Serum troponin T > 0.10 ng/mL (amyloid patients only)

• No known positivity for HIV or active hepatitis infection

• No active deep vein thrombosis or pulmonary embolism that has not been therapeutically anticoagulated

• No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk for participating in the study or confounds the ability to interpret data from the study

• No known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash

• No peripheral neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

• All previous cancer therapy, including chemotherapy and investigational agents, must have been discontinued ≥ 2 weeks prior to study registration

• No radiotherapy ≤ 14 days prior to study registration

• No other concurrent anti-myeloma therapy

• No concurrent radiotherapy, except for palliation of a single painful bone lesion or fracture

• Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone disease

• Willing and able to take aspirin or alternate prophylactic anticoagulation