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A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (CANOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539744
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Pomalidomide Drug: Dexamethasone Drug: Venetoclax Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : January 12, 2021
Estimated Study Completion Date : July 7, 2022


Arm Intervention/treatment
Experimental: Arm 1 VenDex
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Drug: Dexamethasone
oral, locally available form

Drug: Venetoclax
tablet; oral
Other Names:
  • ABT-199
  • GDC-0199

Active Comparator: Arm 2 PomDex
Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Drug: Pomalidomide
capsule, oral
Other Name: Pomalyst

Drug: Dexamethasone
oral, locally available form

Drug: Venetoclax
tablet; oral
Other Names:
  • ABT-199
  • GDC-0199




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 28 months from first randomization ]
    PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Very Good Partial Response or Better Response Rate (VGPR) [ Time Frame: Up to approximately 28 months from first randomization ]
    VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.

  2. Overall Response Rate (ORR) [ Time Frame: Up to approximately 28 months from first randomization ]
    ORR is defined as the proportion of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.

  3. Overall survival (OS) [ Time Frame: Up to approximately 37 months from first randomization ]
    OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.

  4. Duration of response (DOR) [ Time Frame: Up to approximately 28 months from first randomization ]
    DOR for a participant is defined as the number of days from the date of first documented response (PR or better) to the date of first documented PD or death due to multiple myeloma, whichever occurs first.

  5. Time to Disease Progression (TTP) [ Time Frame: Up to approximately 28 months from first randomization ]
    TTP for a participant is defined as the number of days from the date of randomization to the date of first documented PD or death due to multiple myeloma, whichever occurs first.

  6. Time to Response (TTR) [ Time Frame: Up to approximately 28 months from first randomization ]
    TTR for a participant is defined as the number of days from the date of randomization to the date of first documented response (PR or better).

  7. Minimal Residual Disease (MRD) Negativity Rate [ Time Frame: Up to approximately 28 months from first randomization ]
    MRD defined as the proportion of participants with MRD negativity status. MRD negativity will be defined at 10^-5 threshold as measured by centralized testing of bone marrow aspirate samples by next generation sequencing (NGS).

  8. Cmax of Venetoclax [ Time Frame: Up to approximately 225 days from initial dose ]
    Maximum plasma concentration (Cmax) of venetoclax

  9. Trough Concentration (Ctrough) of Venetoclax [ Time Frame: Up to approximately 225 days from initial dose ]
    Observed plasma concentration at trough (Ctrough) of venetoclax.

  10. Change from Baseline in PROMIS Fatigue Score. [ Time Frame: Up to approximately 28 months from first randomization ]
    Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.

  11. Change from Baseline in BPI-SF Worst Pain Score [ Time Frame: Up to approximately 28 months from first randomization ]
    Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.

  12. Change from Baseline in EORTC QLQ-30 Physical Functioning Score [ Time Frame: Up to approximately 28 months from first randomization ]
    Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30) Physical Functioning Score.

  13. Change from Baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score [ Time Frame: Up to approximately 28 months from first randomization ]
    Change from baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma (MM) based on standard IMWG criteria.
  • Measurable disease at screening as defined per protocol.
  • Has received at least 2 prior lines of therapy as described in the protocol.
  • Has had documented disease progression on or within 60 days after completion of the last therapy.
  • Has received at least 2 consecutive cycles of lenalidomide and be refractory to lenalidomide, as defined per protocol.
  • Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
  • Has MM positive for t(11;14).
  • An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
  • Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.

Exclusion Criteria:

  • History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
  • History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
  • Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
  • Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
  • Known meningeal involvement of MM.
  • Concurrent conditions as listed in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539744


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Hide Hide 108 study locations
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United States, California
VA Central California Health C /ID# 200047 Recruiting
Fresno, California, United States, 93703
University of California, Los Angeles /ID# 171524 Recruiting
Los Angeles, California, United States, 90095
United States, Florida
Mayo Clinic /ID# 200075 Recruiting
Jacksonville, Florida, United States, 32224
Cleveland Clinic Foundation-Florida /ID# 208884 Not yet recruiting
Weston, Florida, United States, 33331-3609
United States, Kentucky
Norton Cancer Institute /ID# 200834 Recruiting
Louisville, Kentucky, United States, 40202-3700
United States, Michigan
Karmanos Cancer Institute /ID# 201377 Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Hospital /ID# 171531 Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic - /ID# 201091 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Ohio
Fairview Hospital - Moll Pavilion /ID# 208919 Not yet recruiting
Cleveland, Ohio, United States, 44111-5605
Cleveland Clinic Main Campus /ID# 202247 Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
UPMC Hillman Cancer Ctr /ID# 200063 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
MD Anderson Cancer Center at Texas Medical Center /ID# 200060 Recruiting
Houston, Texas, United States, 77030-4000
Australia, New South Wales
Liverpool Hospital /ID# 202431 Recruiting
Liverpool, New South Wales, Australia, 2170
Wollongong Hospital /ID# 205545 Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Icon Cancer Care - Townsville /ID# 206565 Recruiting
Hyde Park, Queensland, Australia, 4812
Icon Cancer Centre /ID# 205663 Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
The Queen Elizabeth Hospital /ID# 202432 Recruiting
Woodville, South Australia, Australia, 5011
Australia, Western Australia
Perth Blood Institute Ltd /ID# 206649 Recruiting
Nedlands, Western Australia, Australia, 6009
China, Beijing
Beijing chaoyang hospital, capital medical university /ID# 216014 Not yet recruiting
Beijing, Beijing, China, 100020
Peking University Third Hospital /ID# 216371 Not yet recruiting
Beijing, Beijing, China, 100191
China, Fujian
Fujian Medical Univ Union Hosp /ID# 215832 Not yet recruiting
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong Provincial People's Hospital /ID# 215860 Not yet recruiting
Guangzhou, Guangdong, China, 510080
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 216954 Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Liaoning
First Hospital of China Medical University /ID# 215996 Not yet recruiting
Shenyang, Liaoning, China, 110001
China, Shanghai
Shanghai Changzheng Hospital /ID# 215838 Not yet recruiting
Shanghai, Shanghai, China, 200003
Ruijin Hospital, Shanghai Jiaotong /ID# 216643 Not yet recruiting
Shanghai, Shanghai, China, 200025
China, Tianjin
Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 216041 Not yet recruiting
Tianjin, Tianjin, China, 300020
China, Zhejiang
1st Hosp College Med Zhejian /ID# 215989 Not yet recruiting
Hangzhou, Zhejiang, China, 310003
China
Peking Union Medical College H /ID# 216040 Not yet recruiting
Beijing, China, 100730
West China Hospital, Sichuan University /ID# 216647 Not yet recruiting
Chengdu, China, 610041
The First Affiliated Hospital /ID# 216094 Not yet recruiting
Soochow, China, 215006
Wuhan Union Hospital of Tongji /ID# 216648 Not yet recruiting
Wuhan, China, 430022
Henan Cancer Hospital /ID# 215987 Not yet recruiting
Zhengzhou, Henan, China, 450008
Czechia
Fakultni nemocnice Ostrava /ID# 204515 Recruiting
Ostrava, Praha 5, Czechia, 708 52
Fakultni Nemocnice Brno /ID# 204512 Recruiting
Brno, Czechia, 625 00
France
CHRU Lille - Hôpital Claude Huriez /ID# 202213 Recruiting
Lille CEDEX, Hauts-de-France, France, 59045
CHU Nancy - Brabois /ID# 201076 Recruiting
Vandoeuvre-Lès-Nancy, Lorraine, France, 54500
Centre Hospitalier Lyon Sud /ID# 200097 Recruiting
Pierre Benite CEDEX, Rhone, France, 69495
CHU Henri Mondor /ID# 202211 Recruiting
Creteil, France, 94000
CHU de Nantes, Hotel Dieu -HME /ID# 200099 Recruiting
Nantes, France, 44093
Hopital Pitie Salpetriere /ID# 214173 Recruiting
Paris, France, 75651
Germany
Univ Hosp Schleswig-Holstein /ID# 201830 Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Charite-Univ. Berlin, Benjamin-Franklin /ID# 200051 Recruiting
Berlin, Germany, 12203
Universitaetsklinikum Hamburg /ID# 215495 Not yet recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Jena /ID# 201254 Recruiting
Jena, Germany, 07747
Univ-Klinikum Wuerzburg /ID# 200055 Recruiting
Wuerzburg, Germany, 97080
Greece
Alexandra General Hospital /ID# 202386 Recruiting
Athens, Attiki, Greece, 11528
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982 Not yet recruiting
Athens, Greece, 10676
University Gen Hosp of Patra /ID# 201691 Recruiting
Patras, Greece, 26504
Theageneio Anticancer Hospital /ID# 213983 Not yet recruiting
Thessaloniki, Greece, 54639
G. Papanikolaou Hospital /ID# 201692 Recruiting
Thessaloniki, Greece, 57010
Israel
Sheba Medical Center /ID# 169778 Recruiting
Ramat Gan, Tel-Aviv, Israel, 52621
Bnai Zion Medical Center /ID# 169466 Recruiting
Haifa, Israel, 3339419
Rambam Medical Center /ID# 169678 Recruiting
Haifa, Israel, 3525408
Hadassah /ID# 169474 Recruiting
Jerusalem, Israel, 91120
Tel Aviv Medical Center /ID# 169437 Recruiting
Tel Aviv, Israel, 6423906
Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 170952 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 212498 Not yet recruiting
Milan, Lombardia, Italy, 20122
AOU Ospedali Riuniti di Ancona - G.M. Lancisi, G. Salesi /ID# 170950 Recruiting
Ancona, Marche, Italy, 60126
AOU Citta della Salute Scienza /ID# 170962 Not yet recruiting
Turin, Piemonte, Italy, 10126
Irccs-Crob /Id# 170955 Recruiting
Rionero in Vulture, Italy, 85028
A.O. Santa Maria /ID# 170948 Recruiting
Terni, Italy, 05100
Japan
Nagoya City University Hospital /ID# 170880 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Kyushu University Hospital /ID# 171117 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Ogaki Municipal Hospital /ID# 171043 Recruiting
Ogaki-shi, Gifu, Japan, 503-8502
Gunma University Hospital /ID# 170966 Recruiting
Maebashi-shi, Gunma, Japan, 371-8511
Kobe City Medical Center General Hospital /ID# 170992 Recruiting
Kobe-shi, Hyogo, Japan, 650-0047
Hitachi General Hospital /ID# 200843 Recruiting
Hitachi-shi, Ibaraki, Japan, 317-0077
Tohoku University Hospital /ID# 201935 Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Okayama Medical Center /ID# 200119 Recruiting
Okayama-shi, Okayama, Japan, 701-1192
Japanese Red Cross Osaka Hospi /ID# 171493 Recruiting
Osaka-shi, Osaka, Japan, 543-8555
Osaka University Hospital /ID# 201966 Recruiting
Suita-shi, Osaka, Japan, 565-0871
Tokushima University Hospital /ID# 202571 Recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
Japanese Red Cross Medical Center /ID# 171256 Recruiting
Shibuya-ku, Tokyo, Japan, 150-8935
Korea, Republic of
Gachon University Gil Medical Center /ID# 202827 Recruiting
Incheon, Incheon Gwang Yeogsi, Korea, Republic of, 21565
Yonsei University Health System, Severance Hospital /ID# 202709 Recruiting
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 202710 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Seoul National University Hospital /ID# 202711 Recruiting
Seoul, Korea, Republic of, 03080
Russian Federation
Moscow State budget healthcare /ID# 169685 Recruiting
Moscow, Moskva, Russian Federation, 125284
City Clinical Hospital 52 /ID# 206289 Recruiting
Moscow, Russian Federation, 123182
LLC Novaya Clinica /ID# 169689 Recruiting
Pyatigorsk, Russian Federation, 357532
SBI of Health Leningrad regional clinical hospital /ID# 202776 Recruiting
Saint. Petersburg, Russian Federation, 194291
Almazov North-West Federal Med /ID# 169681 Recruiting
Sankt-peterburg, Russian Federation, 197341
Singapore
National University Hospital ( /ID# 203988 Not yet recruiting
Singapore, Singapore, 119228
Singapore General Hospital /ID# 202131 Recruiting
Singapore, Singapore, 169608
Tan Tock Seng Hospital /ID# 204374 Recruiting
Singapore, Singapore, 308433
Spain
Institut Catala d'Oncologia /ID# 171311 Recruiting
Girona, Spain, 17007
Hospital Fundacion Jimenez Dia /ID# 171304 Recruiting
Madrid, Spain, 28040
Hospital 12 de Octubre /ID# 171288 Recruiting
Madrid, Spain, 28041
Hospital Clinico Univ de Salamanca /ID# 171294 Recruiting
Salamanca, Spain, 37007
Hospital Virgen del Rocio /ID# 171286 Recruiting
Sevilla, Spain, 41013
Sweden
Sunderby sjukhus /ID# 201314 Recruiting
Luleå, Norrbottens Lan, Sweden, 971 80
Södra Älvsborgs sjukhus /ID# 213061 Recruiting
Borås, Vastra Gotalands Lan, Sweden, 501 82
Universitetssjukhuset Linköping /ID# 200789 Completed
Linkoping, Vastra Gotalands Lan, Sweden, 581 85
Uddevalla sjukhus /ID# 201315 Recruiting
Uddevalla, Vastra Gotalands Lan, Sweden, 451 80
Turkey
Cukurova Universitesi Tip Fakultesi /ID# 201955 Recruiting
Saricam Adana, Adana, Turkey, 01330
Medical Park İzmir Hastanesi /ID# 201954 Recruiting
Karşiyaka, Izmir, Turkey, 35575
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi /ID# 201956 Recruiting
Ankara, Turkey, 06200
Ankara Univ Medical Faculty /ID# 201881 Recruiting
Ankara, Turkey, 6100
Istanbul University Istanbul Medical Faculty /ID# 201953 Recruiting
Istanbul, Turkey, 34093
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952 Recruiting
Istanbul, Turkey, 34899
United Kingdom
Beatson Oncology Centre /ID# 202199 Recruiting
Glasgow, United Kingdom, G11 6NT
UCLH, University College Hospi /ID# 171428 Recruiting
London, United Kingdom, NW1 2PG
QE Woolwich, Lewisham and Gree /ID# 171445 Recruiting
London, United Kingdom, SE18 4QH
Hammersmith Hospital, Imperial /ID# 171446 Recruiting
London, United Kingdom, W12 0HS
Manchester Royal Infirmary, Ma /ID# 171440 Recruiting
Manchester, United Kingdom, M13 9WL
Queen Alexandra Hospital, Port /ID# 171444 Recruiting
Portsmouth, United Kingdom, PO6 3LY
Royal Hallamshire Hospital, Sh /ID# 171447 Recruiting
Sheffield, United Kingdom, S10 2RX
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03539744    
Other Study ID Numbers: M13-494
2017-003838-88 ( EudraCT Number )
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Cancer
Multiple Myeloma (MM)
Relapsed or Refractory Multiple Myeloma (R/R MM)
pharmacokinetics
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Venetoclax
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal