Multiple Myeloma and Plasma Cell NeoplasmPhase 3NCT00002678
Combination Chemotherapy in Treating Patients With Multiple Myeloma
A Phase 3 study testing dexamethasone, melphalan and prednisone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 37 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- dexamethasone, melphalan and prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 2 Jun 1995to 21 Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven previously untreated stage I-III multiple myeloma
- Patients with stage I disease must be symptomatic
- Must meet at least 1 of the following conditions:
- Plasma cells in osteolytic lesion or soft tissue tumor biopsy
- At least 10% plasmacytosis in bone marrow aspirate and/or biopsy
- Less than 10% plasma cells in bone marrow but at least 1 bony lesion
- Detectable serum M-component of IgG, IgA, IgD, or IgE
- If only light chain disease (urine M-protein) present, urinary excretion of light chain (Bence Jones) protein must be at least 1.0 g/24 hours
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-4
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other concurrent serious illness
- Concurrent diabetes allowed, at the discretion of the treating physician, if changes in insulin requirements can be managed
- No other prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunizations
- No concurrent filgrastim (G-CSF) or other growth factors as prophylaxis
- Concurrent epoetin alfa for anemia allowed
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior dexamethasone or prednisone with radiotherapy for spinal cord compression allowed if cumulative dexamethasone dose no greater than 120 mg and cumulative prednisone dose no greater than 792 mg
- Prior or concurrent corticosteroids for hypercalcemia allowed
Radiotherapy:
- See Endocrine therapy
- Prior focal radiotherapy allowed
- Concurrent focal radiotherapy during induction allowed
- Concurrent radiotherapy for palliation (e.g., painful osteolytic lesions or spinal cord compression) allowed
Surgery:
- At least 2 years since prior surgery for radiologic or endoscopic diagnosis of gastric or duodenal ulcer
Other:
- At least 2 years since prior medication for radiologic or endoscopic diagnosis of gastric or duodenal ulcer
- Prior or concurrent bisphosphonates for hypercalcemia allowed
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
Canada36 sites
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, P3E 5J1
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 2Y9
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
McGill University
Montreal, Quebec, H2W 1S6
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Hopital de L'Enfant Jesus
Québec, Quebec, G1J 1Z4
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, G1S 4L8
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Algoma District Medical Group
Sault Ste. Marie, Ontario, P6B 1Y5
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Providence Health Care - Vancouver
Vancouver, British Columbia, V6Z 1Y6
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
United States1 site
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805
About this study
Official title: Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
Read the detailed description
OBJECTIVES:
- Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.
- Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.
- Compare the time to progression, response rate, and quality of life of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).
- Induction: Patients are randomized to 1 of 4 treatment arms.
- Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4.
- Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3.
Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy.
- Maintenance:
- Arms I and III: Patients undergo observation.
- Arms II and IV: Patients receive oral DM on days 1-4. Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity. Patients on arms I-IV who develop disease progression proceed to reinduction.
- Reinduction: Patients restart induction on the arm to which they were originally randomized. Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks, disease progression, or unacceptable toxicity. Patients who achieve a stable response lasting 16 weeks restart maintenance therapy. Patients who experience further disease progression during reinduction are taken off study.
Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.
- Being tested
- dexamethasone, melphalan, prednisone
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy.
melphalanDrug
9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
prednisoneDrug
100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
| Study group | Role | What they receive |
|---|---|---|
| Melphan plus prednisone | Active comparator | melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response. Receives: Drug: melphalan; Drug: prednisone |
| Melphan, prednisone pluse dexamethasone | Active comparator | melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To compare overall survival between:
- patients receiving melphalan-prednisone and those receiving melphalan-dexamethasone as induction therapy ii) patients maintained by dexamethasone and those on no additional treatment in the subgroup whose disease has not progressed at the time of the 12th induction cycle
Measured: 9 years
Secondary outcomes (4)
Time to progression
Measured: 9 years
Response rates
Measured: 9 years
Toxicity
Measured: 9 years
Quality of Life
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start2 Jun 1995
- Primary completion3 May 2004
- Study completion21 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Chaim Shustik, MD, Study chair, Royal Victoria Hospital - Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002678
- Sponsor's protocol ID
- MY7
- Other IDs
- CAN-NCIC-MY7, NCI-V95-0713, CDR0000064328
- Status last verified
- Mar 2020
- First submitted
- 1 Nov 1999
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shustik C, Belch A, Robinson S, Rubin SH, Dolan SP, Kovacs MJ, Grewal KS, Walde D, Barr R, Wilson J, Gill K, Vickars L, Rudinskas L, Sicheri DA, Wilson K, Djurfeldt M, Shepherd LE, Ding K, Meyer RM. A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7. Br J Haematol. 2007 Jan;136(2):203-11. doi: 10.1111/j.1365-2141.2006.06405.x.
PubMed 17233817Shustik C, Belch A, Robinson S, et al.: Dexamethasone (dex) maintenance versus observation (obs) in patients with previously untreated multiple myeloma: a National Cancer Institute of Canada Clinical Trials Group study: MY.7. [Abstract] J Clin Oncol 22 (Suppl 14): A-6510, 560s, 2004.
Shustik C, Belch A, Meyer R, et al.: Melphalan-dexamethasone is not superior to melphalan-prednisone as induction therapy in multiple myeloma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1191, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
- ClinicalTrials.gov ID
- NCT00002678
- Acronym / sponsor ID
- MY7
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 2 Jun 1995 (actual)
- Primary completion
- 3 May 2004 (actual)
- Study completion
- 21 Dec 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
Detailed description
OBJECTIVES:
- Compare the overall survival of patients with previously untreated stage I-III multiple myelome treated with melphalan combined with dexamethasone or prednisone as induction therapy.
- Compare the overall survival of patients with stable or responding disease after induction treated with dexamethasone vs observation alone as maintenance therapy.
- Compare the time to progression, response rate, and quality of life of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).
- Induction: Patients are randomized to 1 of 4 treatment arms.
- Arms I and II: Patients receive induction comprising oral prednisone followed by oral melphalan on days 1-4.
- Arms III and IV: Patients receive induction comprising oral melphalan and oral dexamethasone (DM) on days 1-4 of all courses and DM on days 15-18 of courses 1-3.
Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy.
- Maintenance:
- Arms I and III: Patients undergo observation.
- Arms II and IV: Patients receive oral DM on days 1-4. Maintenance therapy continues every 4 weeks for arms II and IV and every 3 months for arms I and III in the absence of disease progression or unacceptable toxicity. Patients on arms I-IV who develop disease progression proceed to reinduction.
- Reinduction: Patients restart induction on the arm to which they were originally randomized. Reinduction continues every 4 weeks in the absence of stable response lasting 16 weeks, disease progression, or unacceptable toxicity. Patients who achieve a stable response lasting 16 weeks restart maintenance therapy. Patients who experience further disease progression during reinduction are taken off study.
Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melphan plus prednisone | Active comparator | Drug: melphalan, Drug: prednisonemelphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response. |
| Melphan, prednisone pluse dexamethasone | Active comparator | Drug: dexamethasonemelphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy. | Drug | Melphan, prednisone pluse dexamethasone |
| melphalan9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks | Drug | Melphan plus prednisone |
| prednisone100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan | Drug | Melphan plus prednisone |
Primary outcome
Overall survival
Time frame: 9 years
To compare overall survival between: i) patients receiving melphalan-prednisone and those receiving melphalan-dexamethasone as induction therapy ii) patients maintained by dexamethasone and those on no additional treatment in the subgroup whose disease has not progressed at the time of the 12th induction cycle
4 secondary outcomes
Time to progression
Time frame: 9 years
Response rates
Time frame: 9 years
Toxicity
Time frame: 9 years
Quality of Life
Time frame: 9 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Results publication: PubMed 17233817Shustik C, Belch A, Robinson S, Rubin SH, Dolan SP, Kovacs MJ, Grewal KS, Walde D, Barr R, Wilson J, Gill K, Vickars L, Rudinskas L, Sicheri DA, Wilson K, Djurfeldt M, Shepherd LE, Ding K, Meyer RM. A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7. Br J Haematol. 2007 Jan;136(2):203-11. doi: 10.1111/j.1365-2141.2006.06405.x.
- Results publicationShustik C, Belch A, Robinson S, et al.: Dexamethasone (dex) maintenance versus observation (obs) in patients with previously untreated multiple myeloma: a National Cancer Institute of Canada Clinical Trials Group study: MY.7. [Abstract] J Clin Oncol 22 (Suppl 14): A-6510, 560s, 2004.
- Results publicationShustik C, Belch A, Meyer R, et al.: Melphalan-dexamethasone is not superior to melphalan-prednisone as induction therapy in multiple myeloma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1191, 2001.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaim Shustik, MD study chair
Royal Victoria Hospital - Montreal
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone, melphalan and prednisone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by NCIC Clinical Trials Group at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002678, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.