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Trial Title: Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting

NCT ID: NCT01946477

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Daratumumab
Pomalidomide

Conditions: Keywords:
Multiple Myeloma, MM, cancer, oncology, hematology, plasma, neoplasm, plasmacytoma

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Pomalidomide
Arm group label: Pomalidomide + Dexamethasone + Daratumumab
Arm group label: Pomalidomide + dexamethasone

Other name: CC-4047

Intervention type: Drug
Intervention name: Dexamethasone
Arm group label: Pomalidomide + Dexamethasone + Daratumumab
Arm group label: Pomalidomide + dexamethasone

Other name: dex

Intervention type: Drug
Intervention name: Daratumumab
Arm group label: Pomalidomide + Dexamethasone + Daratumumab

Summary: This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy. This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.

Detailed description: A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting. This trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Subjects must satisfy the following criteria to be enrolled in the study: 1. Adults (age ≥ 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours). 2. Subjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy. 3. All subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen. 4. All subjects must have documented disease progression during or after their last antimyeloma therapy. 5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 6. Subjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted. 7. Subjects must be able to adhere to the study visit schedule and other protocol requirements. 8. All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes. 9. Females with child-bearing potential (FCBP†) must agree to use 2 reliable forms of contraception* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab. 10. Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab. 11. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab. 12. Males must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab. 13. All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment. 14. All subjects must agree not to share medication. Exclusion Criteria: The presence of any of the following will exclude a subject from study enrollment: 1. Any of the following laboratory abnormalities: • Absolute neutrophil count < 1,000/μL • Platelet count < 75,000/μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/μL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells. • Severe renal impairment (Creatinine Clearance [CrCl] < 30 mL/min) requiring dialysis. - Corrected serum calcium > 11.5 mg/dL (> 2.8 mmol/L) - Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior red blood cell transfusion or recombinant human erythropoietin use is permitted) - Serum SGOT/AST or SGPT/ALT > 3.0 x the upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia 2. Prior history of malignancies, other than MM, unless the subject has been free of the disease for more than 5 years. Allowed exceptions include the following: •Basal or squamous cell carcinoma of the skin •Carcinoma in situ of the cervix or breast • Incidental histological finding of prostate cancer (TNM [tumor, nodes, metastasis] stage of T1a or T1b) 3. Previous therapy with pomalidomide or daratumumab 4. Hypersensitivity to thalidomide, LEN, or dex (this includes ≥ Grade 3 rash during prior thalidomide or LEN therapy) 5. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment. 6. Subjects with any one of the following: • Congestive heart failure (NY Heart Association Class III or IV) - Myocardial infarction within 12 months prior to starting study treatment - Unstable or poorly controlled angina pectoris, including Prinzmetal's variant angina pectoris 7. Subjects who received any of the following within 14 days of initiation of study treatment: • Major surgery (kyphoplasty is not considered major surgery) • Use of any anti-myeloma drug therapy 8. Use of any investigational agents including for the treatment of multiple myeloma within 28 days or 5 half-lives (whichever is longer) of treatment, unless approved by the sponsor. 9. Incidence of gastrointestinal disease that may significantly alter the oral absorption of Pomalidomide. 10. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment 11. Any serious medical condition, laboratory abnormality, or psychiatric illness, that would preclude participation in the study, or interfere with interpretation of the study results 12. Pregnant or breastfeeding females 13. Known human immunodeficiency virus (HIV) positivity; active infectious hepatitis A, B, or C; or chronic hepatitis B or C All subjects will be tested for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (antiHBs), and hepatitis B core antibody (antiHBc). Subjects with the following serological testing are considered not eligible: - HBsAg positive - HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA Note: - Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, viral DNA negative are eligible. For these subjects, DNA monitoring and prophylactic medication for HBV reactivation are recommended per local practice. - Subjects who are seropositive because of hepatitis B virus vaccination are eligible (anti-HBs positive, anti-HBc negative, and HBsAg negative). All subjects will be tested for hepatitis C antibody. Subjects are not eligible if known seropositive for hepatitis C virus. Note: • Subjects who are hepatitis C antibody positive but show no detectable viral RNA for 6 months prior to initiation of study treatment are eligible. 14. For subjects enrolling in Cohort B and Cohort C - Subject has known allergies, hypersensitivity to mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the Daratumumab IB), or known sensitivity to mammalian-derived products.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Arizona Cancer Center

Address:
City: Tucson
Zip: 85724
Country: United States

Facility:
Name: Marin Oncology Associates

Address:
City: Greenbrae
Zip: 94904-2007
Country: United States

Facility:
Name: Local Institution - 109

Address:
City: Los Angeles
Zip: 90095-1670
Country: United States

Facility:
Name: Bay Area Cancer Research Group, LLC

Address:
City: Pleasant Hill
Zip: 94523
Country: United States

Facility:
Name: Local Institution - 108

Address:
City: Whittier
Zip: 90603
Country: United States

Facility:
Name: Local Institution - 138

Address:
City: Denver
Zip: 80218
Country: United States

Facility:
Name: Local Institution - 120

Address:
City: Stamford
Zip: 06902
Country: United States

Facility:
Name: Cancer Specialist of North Florida

Address:
City: Jacksonville
Zip: 32256
Country: United States

Facility:
Name: Local Institution - 127

Address:
City: Orlando
Zip: 32804
Country: United States

Facility:
Name: Local Institution - 133

Address:
City: Pembroke Pines
Zip: 33028
Country: United States

Facility:
Name: Local Institution - 136

Address:
City: Saint Petersburg
Zip: 33705
Country: United States

Facility:
Name: Local Institution - 134

Address:
City: Fairway
Zip: 66205
Country: United States

Facility:
Name: Cotton O'Neil Clinical Research, Hematology and Oncology

Address:
City: Topeka
Zip: 66606
Country: United States

Facility:
Name: Local Institution - 124

Address:
City: Louisville
Zip: 40207
Country: United States

Facility:
Name: Carroll Regional Cancer Center

Address:
City: Westminster
Zip: 21157
Country: United States

Facility:
Name: Saint John Hospital and Medical Center

Address:
City: Gross Pointe
Zip: 48236
Country: United States

Facility:
Name: St. Luke's Hospital

Address:
City: Kansas City
Zip: 64111
Country: United States

Facility:
Name: Local Institution - 110

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: Local Institution - 118

Address:
City: East Orange
Zip: 07018
Country: United States

Facility:
Name: Local Institution - 101

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10467
Country: United States

Facility:
Name: CR Wood Cancer Center

Address:
City: Glens Falls
Zip: 12801
Country: United States

Facility:
Name: Local Institution - 130

Address:
City: Durham
Zip: 27705
Country: United States

Facility:
Name: Local Institution - 123

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: Local Institution - 121

Address:
City: Cleveland
Zip: 44111
Country: United States

Facility:
Name: Local Institution - 115

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Local Institution - 122

Address:
City: Mayfield Heights
Zip: 44124
Country: United States

Facility:
Name: Local Institution - 107

Address:
City: Hershey
Zip: 17033-0850
Country: United States

Facility:
Name: Local Institution - 135

Address:
City: Chattanooga
Zip: 37404
Country: United States

Facility:
Name: Local Institution - 131

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: Local Institution - 128

Address:
City: Lubbock
Zip: 79410
Country: United States

Facility:
Name: Texas Health Physicians Group

Address:
City: Plano
Zip: 75093
Country: United States

Facility:
Name: Local Institution - 106

Address:
City: Spokane
Zip: 99218
Country: United States

Facility:
Name: Local Institution - 113

Address:
City: Calgary
Zip: T2N 2T9
Country: Canada

Facility:
Name: Local Institution - 144

Address:
City: Surrey
Zip: V3V 1Z2
Country: Canada

Facility:
Name: Local Institution - 114

Address:
City: Vancouver
Zip: V5Z 4E6
Country: Canada

Facility:
Name: Local Institution - 139

Address:
City: Moncton
Zip: E1C 8X3
Country: Canada

Facility:
Name: Local Institution - 140

Address:
City: St John's
Zip: A1B3V6
Country: Canada

Facility:
Name: Local Institution - 112

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Local Institution - 148

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Local Institution - 117

Address:
City: Montreal
Zip: H3A 1A1
Country: Canada

Facility:
Name: Local Institution - 205

Address:
City: Fukuoka
Zip: 810-8563
Country: Japan

Facility:
Name: Local Institution - 208

Address:
City: Kamogawa
Zip: 296-8602
Country: Japan

Facility:
Name: Local Institution - 204

Address:
City: Kyoto-city
Zip: 602-8566
Country: Japan

Facility:
Name: Local Institution - 202

Address:
City: Nagoya
Zip: 467-8602
Country: Japan

Facility:
Name: Local Institution - 203

Address:
City: Okayama
Zip: 701-1192
Country: Japan

Facility:
Name: Local Institution - 206

Address:
City: Shibukawa-shi, Gunma-ken
Zip: 377-0280
Country: Japan

Facility:
Name: Local Institution - 207

Address:
City: Toyohashi
Zip: 441-8570
Country: Japan

Facility:
Name: Local Institution - 119

Address:
City: San Juan
Zip: 00927
Country: Puerto Rico

Start date: May 29, 2014

Completion date: May 24, 2025

Lead sponsor:
Agency: Celgene
Agency class: Industry

Source: Celgene

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01946477
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/s/US/English/USenHome
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

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