Multiple Myeloma Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

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).
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.
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.
All subjects must have documented disease progression during or after their last antimyeloma therapy.
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Subjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.
Subjects must be able to adhere to the study visit schedule and other protocol requirements.
All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.
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.
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.
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.
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.
All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.

All subjects must agree not to share medication.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

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

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)

Previous therapy with pomalidomide or daratumumab
Hypersensitivity to thalidomide, LEN, or dex (this includes ≥ Grade 3 rash during prior thalidomide or LEN therapy)
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.

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

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

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.
Incidence of gastrointestinal disease that may significantly alter the oral absorption of Pomalidomide.
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
Any serious medical condition, laboratory abnormality, or psychiatric illness, that would preclude participation in the study, or interfere with interpretation of the study results
Pregnant or breastfeeding females

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.

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

186

Study ID:

NCT01946477

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 48 Locations for this study

See Locations Near You

University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Marin Oncology Associates
Greenbrae California, 94904, United States
Local Institution - 109
Los Angeles California, 90095, United States
University of California at Los Angeles
Los Angeles California, 90095, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill California, 94523, United States
Innovative Clinical Research Institute
Whittier California, 90603, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Local Institution - 138
Denver Colorado, 80218, United States
Stamford Hospital
Stamford Connecticut, 06902, United States
Cancer Specialist of North Florida
Jacksonville Florida, 32256, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Memorial West Cancer Institute
Pembroke Pines Florida, 33028, United States
Florida Cancer Specialists North Region Sarah Cannon Research
Saint Petersburg Florida, 33705, United States
University of Kansas Cancer Center
Fairway Kansas, 66205, United States
Cotton O'Neil Clinical Research, Hematology and Oncology
Topeka Kansas, 66606, United States
Norton Cancer Institute Louisville Oncology
Louisville Kentucky, 40207, United States
Carroll Regional Cancer Center
Westminster Maryland, 21157, United States
Saint John Hospital and Medical Center
Gross Pointe Michigan, 48236, United States
St. Luke's Hospital
Kansas City Missouri, 64111, United States
Washington University
Saint Louis Missouri, 63110, United States
Veterans Affairs New Jersey Health Care System
East Orange New Jersey, 07018, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
CR Wood Cancer Center
Glens Falls New York, 12801, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44111, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Local Institution - 115
Cleveland Ohio, 44195, United States
Cleveland Clinic
Mayfield Heights Ohio, 44124, United States
Penn State Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Tennessee Oncology
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Joe Arrington Cancer Center
Lubbock Texas, 79410, United States
Texas Health Physicians Group
Plano Texas, 75093, United States
Cancer Care Northwest
Spokane Washington, 99218, United States
Foothills Hospital
Calgary Alberta, T2N 2, Canada
Local Institution - 113
Calgary Alberta, T2N 2, Canada
Fraser Valley Centre
Surrey British Columbia, V3V 1, Canada
British Columbia Cancer Agency
Vancouver British Columbia, V5Z 4, Canada
Vitalite Health Network
Moncton New Brunswick, E1C 8, Canada
Health Sciences Center
St John's Newfoundland and Labrador, A1B3V, Canada
Local Institution - 112
Toronto Ontario, M5G 2, Canada
Local Institution - 148
Toronto Ontario, M5G 2, Canada
Princess Margaret Hospital University Health Network
Toronto Ontario, M5G 2, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Royal Victoria Hospital
Montreal Quebec, H3A 1, Canada
National Hospital Organization Kyushu Medical Center
Fukuoka , 810-8, Japan
Kameda Medical Center
Kamogawa , 296-8, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city , 602-8, Japan
Local Institution - 202
Nagoya , 467-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
Okayama Medical Center
Okayama , 701-1, Japan
Shibukawa Medical Center
Shibukawa-shi, Gunma-ken , 377-0, Japan
Local Institution - 207
Toyohashi , 441-8, Japan
Toyohashi Municipal Hospital
Toyohashi , 441-8, Japan
Fundacion de Investigacion
San Juan , 00927, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

186

Study ID:

NCT01946477

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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