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A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination with Other Treatments in Subjects with Multiple Myeloma

Clinical Trial Details

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 MonoT, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 MonoT, CC-220 in combination with DEX (DoubleT) for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

Key Eligibility: 

Inclusion Criteria

  • All subjects in RRMM cohorts must have a documented diagnosis of Multiple Myeloma and have measurable disease
  • Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio 2. All subjects in RRMM cohorts must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy. Subjects who had CAR T therapy as their last myeloma therapy must have documented disease progression.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 3. Subject must have documented diagnosis with previously untreated symptomatic MM
  • Subjects in Cohort J1 are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation due to age ≥65 years, OR in subjects younger than 65 years: presence of important comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with autologous stem cell transplantation.
  • Subjects in Cohort J2 are considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory data.

Exclusion Criteria

  • Subject has nonsecretory or oligosecretory multiple myeloma
  • Subjects with Plasma Cell leukemia or amyloidosis
  • Certain laboratory abnormalities

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020079

ClinicalTrials.gov:

NCT02773030

Sponsor:

CC-220-MM-001

Status

Open to Enrollment

Age Group

Adult

Sponsor